Devices and methods for placement of partitions within a hollow body organ

ABSTRACT

Devices and methods for tissue acquisition and fixation, or gastroplasty, are described. Generally, the devices of the system may be advanced in a minimally invasive manner within a patient&#39;s body to create one or more plications within the hollow body organ. A tissue treatment device attached to a distal end of a flexible elongated member and has a cartridge member opposite an anvil member. The cartridge member and the anvil member are movable between a closed position and an open position relative to one another, and the cartridge member is re-loadable with a removable staple cartridge to form multiple plications within the organ with the same tissue treatment device.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of co-pending applicationSer. No. 10/797,303 filed on Mar. 9, 2004, which is herein incorporatedby reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical devices and methods.More particularly, it relates to devices and methods for creating apartition within a hollow body organ, particularly a stomach, intestinaltract, or other region of the gastrointestinal tract, and affixing thetissue.

2. General Background and State of the Art

In cases of severe obesity, patients may currently undergo several typesof surgery either to tie off or staple portions of the large or smallintestine or stomach, and/or to bypass portions of the same to reducethe amount of food desired by the patient, and the amount absorbed bythe gastrointestinal tract. The procedures currently available includelaparoscopic banding, where a device is used to “tie off” or constrict aportion of the stomach, vertical banded gastroplasty (VBG), or a moreinvasive surgical procedure known as a Roux-En-Y gastric bypass toeffect permanent surgical reduction of the stomach's volume andsubsequent bypass of the intestine.

Typically, these stomach reduction procedures are performed surgicallythrough an open incision and staples or sutures are applied externallyto the stomach or hollow body organ. Such procedures can also beperformed laparoscopically, through the use of smaller incisions, orports, through trocars and other specialized devices. In the case oflaparoscopic banding, an adjustable band is placed around the proximalsection of the stomach reaching from the lesser curve of the stomacharound to the greater curve, thereby creating a constriction or “waist”in a vertical manner between the esophagus and the pylorus. During aVBG, a small pouch (approximately 20 cc in volume) is constructed byforming a vertical partition from the gastroesophageal junction tomidway down the lesser curvature of the stomach by externally applyingstaples, and optionally dividing or resecting a portion of the stomach,followed by creation of a stoma at the outlet of the partition toprevent dilation of the outlet channel and restrict intake. In aRoux-En-Y gastric bypass, the stomach is surgically divided into asmaller upper pouch connected to the esophageal inflow, and a lowerportion, detached from the upper pouch but still connected to theintestinal tract for purposes of secreting digestive juices. A resectedportion of the small intestine is then anastomosed using an end-to-sideanastomosis to the upper pouch, thereby bypassing the majority of theintestine and reducing absorption of caloric intake and causing rapid“dumping” of highly caloric or “junk foods.”

Although the outcome of these stomach reduction surgeries leads topatient weight loss because patients are physically forced to eat lessdue to the reduced size of their stomach, several limitations exist dueto the invasiveness of the procedures, including time, use of generalanesthesia, time and pain associated with the healing of the incisions,and other complications attendant to major surgery. In addition, theseprocedures are only available to a small segment of the obese population(morbid obesity, Body Mass Index>40) due to their complications, leavingpatients who are considered obese or moderately obese with few, if any,interventional options.

In addition to surgical procedures, certain tools exist for securingtissue such as the stapling devices used in the above-described surgicalprocedures and others such as in the treatment of gastroesophagealreflux disease (GERD). These devices include the GIA® device(Gastrointestinal Anastomosis device manufactured by EthiconEndosurgery, Inc. and a similar product by USSC), and certain clampingand stapling devices as described in U.S. Pat. Nos. 5,403,326;5,571,116; 5,676,674; 5,897,562; 6,494,888; and 6,506,196 for methodsand devices for fundoplication of the stomach to the esophagus for thetreatment of gastroesophageal reflux disease (GERD). In addition,certain tools, such as those described in U.S. Pat. Nos. 5,788,715 and5,947,983, detail an endoscopic suturing device that is inserted throughan endoscope and placed at the site where the esophagus and the stomachmeet. Vacuum is then applied to acquire the adjacent tissue, and aseries of stitches are placed to create a pleat in the sphincter toreduce the backflow of acid from the stomach up through the esophagus.These devices can also be used transorally for the endoscopic treatmentof esophageal varices (dilated blood vessels within the wall of theesophagus).

There is a need for improved devices and procedures. In addition,because of the invasiveness of most of the surgeries used to treatobesity and other gastric disorders such as GERD, and the limitedsuccess of others, there remains a need for improved devices and methodsfor more effective, less invasive hollow organ restriction procedures.

SUMMARY OF THE INVENTION

Devices for tissue acquisition and fixation, or gastroplasty, aredescribed that may be utilized for creating a partition within a hollowbody organ, such as the stomach, esophageal junction, and other portionsof the gastrointestinal tract. Generally, the devices of the system maybe advanced in a minimally invasive manner within a patient's body,e.g., transorally, endoscopically, percutaneously, etc., to create oneor several divisions or plications within the hollow body organ. Suchdivisions or plications can form restrictive barriers within the organ,or can be placed to form a pouch, or gastric lumen, smaller than theremaining stomach volume to essentially act as the active stomach suchas the pouch resulting from a surgical Roux-En-Y gastric bypassprocedure. Examples of placing and/or creating divisions or plicationsmay be seen in further detail in U.S. Pat. No. 6,558,400; U.S. patentapplication Ser. No. 10/188,547 filed Jul. 2, 2002; and U.S. patentapplication Ser. No. 10/417,790 filed Apr. 16, 2003, each of which isincorporated herein by reference in its entirety.

The devices may be advanced within a body through a variety of methods,e.g., transorally, transanally, endoscopically, percutaneously, etc., tocreate one or several divisions or plications within a hollow bodyorgan, e.g., to create a gastric lumen or partition to reduce theeffective active area of the stomach (e.g., that which receives theinitial food volume), performed from within the stomach cavity. Thecreation of this smaller gastric lumen may be achieved in a minimallyinvasive procedure completely from within the stomach cavity. Moreover,the devices are configured such that once acquisition of the tissue isaccomplished, manipulation of the acquired tissue is unnecessary as thedevices are able to automatically configure the acquired tissue into adesired configuration.

The devices may generally comprise a first acquisition member and asecond acquisition member in apposition to one another along a firstlongitudinal axis, wherein optionally, at least one of the acquisitionmembers is adapted to adhere tissue thereto such that the tissue ispositioned between the first and second acquisition members, andoptionally wherein at least one of the acquisition members is movablerelative to the first longitudinal axis between a delivery configurationand a deployment configuration. Moreover, the system may also comprise aseptum, or separator, removably positioned between the first and secondacquisition members, wherein at least one of the acquisition members ismovable relative to the septum between a delivery configuration and adeployment configuration.

A handle may be located at a proximal end of an elongate body or memberand used to manipulate the device advanced within the hollow body organas well as control the opening and clamping of the acquisition membersonto the tissue. The elongate body may be comprised of a series oflinks, or of an extrusion fabricated with various lumens to accommodatethe various control mechanisms of the acquisition device. Similarly, thecontrol mechanisms may be grouped together and sheathed in a thin skinsheath, such as a heat shrink. A working lumen may extend entirelythrough the elongate member and may be sized to provide access to thedistal end for various surgical tools, such as an endoscope or othervisualization device, or therapeutic devices such as snares, excisionaltools, biopsy tools, etc. once the distal end of the assembly ispositioned within the hollow body organ. The acquisition members may bejoined to the elongate body via a passive or active hinge member,adaptable to position the assembly. The acquisition members maygenerally comprise a cartridge member placed longitudinally inapposition to an anvil member. The cartridge member may contain one orseveral fasteners, e.g., staples, clips, etc., which may be actuated viacontrols located proximally on the handle assembly. Moreover, the septumor barrier may be removably positioned between the cartridge member andanvil member and used to minimize or eliminate cross acquisition of thetissue into the cartridge member and/or anvil member.

Methods of placing a partition from within a hollow body organ using thedevices disclosed herein generally comprise positioning a firstacquisition member and a second acquisition member adjacent to a regionof tissue within the hollow body organ, wherein the first and secondacquisition members are in apposition to one another along a firstlongitudinal axis, adhering tissue from the region to each of the firstand second acquisition members, and securing the adhered tissue betweenthe first and second acquisition members. Such a method may also involvepivoting at least one of the acquisition members about the longitudinalaxis to an open or closed configuration. Another method may alsocomprise removing a septum from between the first acquisition member andthe second acquisition member.

While the device is in a delivery configuration, i.e., where thecomponents of the distal working portion of the device (the cartridgemember and anvil member) are disposed such that the cartridge and anvilare directly positioned into apposition about the septum. Once desirablypositioned, one or both of the cartridge member and anvil member may berotated about a pivot or translationally moved in parallel to oneanother. Then, portions of the stomach wall may be acquired by, or drawnwithin their respective openings. The configuration of the cartridgemember and anvil member and the positioning of the device within thestomach are such that this tissue acquisition procedure also enables thedevices to be self-adjusting with respect to the acquired tissue.Moreover, the devices are configured such that portions of the stomachwall are automatically positioned for fixation upon being acquired andthe tissue becomes automatically adjusted or tensioned around theperimeter of the distal working portion of the device in the stomach andwithin the distal working portion inner volume, to achieve the desiredresulting geometry (e.g., small gastric pouch or restrictive partitionor baffle). Because of the manner in which the tissue is acquired, thetissue intimately surrounds the cartridge member and anvil member todefine or calibrate the subsequent volume of the resulting gastriclumen. Thus, the gastric volume may be predetermined by adjusting thevolume of the cartridge member and anvil member, or the use of accessorydevices such as a scope or balloon. As a result, once the desired volumeis known and incorporated in the device, the user can achieve acontrolled acquisition and without intraprocedural adjustments orpositioning requirements.

The septum may act effectively as a barrier between the openings tofacilitate the acquisition of the tissue to their respective openingswhile minimizing or eliminating cross acquisition of the tissue into thecartridge member and/or anvil member. In other alternatives, the septummay be omitted from the device and acquisition of the tissue may beaccomplished by sequentially activating vacuum forces within theopenings. Once the tissue has been acquired, the septum may be removedfrom between the cartridge member and anvil member by translating theseptum distally or proximally of the cartridge member and anvil memberor left within the stomach for later removal.

The cartridge member of the tissue treatment device may be re-loadablewith a removable staple cartridge after forming a plication within thecavity. This allows the same tissue treatment device to form multipleplications within the cavity. A method of treating a stomach cavity mayinclude forming a first plication within the stomach cavity usingstaples from a first removable staple cartridge, which is easily removedfrom the cartridge member. A second removable staple cartridge is theninserted into the cartridge member, and a second plication is formedwithin the stomach cavity using staples from the second removable staplecartridge.

Another method of forming a plication within the stomach cavity mayinclude clamping the cartridge member and the anvil member togethertwice before firing staples into acquired tissue. This method helps toensure that the desired tissue is acquired by the tissue treatmentdevice, and that there are not folds or pleats present in the acquiredtissue. After inserting the tissue treatment device transorally to thestomach cavity, stomach tissue is acquired at a target region fortreatment with the tissue treatment device. The cartridge member andanvil member of the tissue treatment device are then clamped togethergrasping the acquired target tissue, and the stomach cavity can beinsufflated to inspect the acquired target tissue. If the inspectionreveals that the tissue acquired is not the targeted tissue or thatthere are folds or pleats within the acquired tissue, the acquiredtissue can be released from the tissue treatment device and re-acquired.If the inspection reveals the acquired tissue would form a desiredsleeve, then the stomach cavity can be desufflated once again, and thecartridge member and the anvil member can be unclamped into an openconfiguration, to fully acquire the tissue. The tissue treatment devicemay include a barrier such as a septum, in which case the barrier wouldbe removed from between the cartridge member and the anvil member. Afterwhich, the cartridge member and anvil member are clamped together asecond time and the stomach cavity is again insufflated to inspect theacquired tissue. If the inspection reveals a desired formation betweenthe folds of acquired tissue, the cartridge member and anvil member arefully clamped together and the acquired tissue is plicated to form agastric sleeve within the stomach cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B show side and detailed side views, respectively, of onevariation of an exemplary gastroplasty device described herein.

FIGS. 2A and 2B show perspective detailed views of an exemplarygastroplasty device described herein.

FIGS. 3A and 3B show perspective and end views, respectively, of across-sectioned portion of an exemplary gastroplasty device.

FIGS. 4A and 4B show representative illustrations of how a gastroplastydevice may be advanced transorally through the esophagus of a patientand positioned within the stomach cavity of a stomach.

FIGS. 5A to 5D show end views of an example of how an exemplarygastroplasty device may be used to acquire and fasten tissue within ahollow body organ.

FIG. 5E illustrates a resulting fastened gastric lumen that may beformed using the gastroplasty devices described herein.

FIGS. 5F and 5G demonstrate how a distal working portion of agastroplasty device, and an inner volume, respectively, help to definethe final configuration of the acquired tissue.

FIGS. 5H and 5I show perspective and cross sectional views ofillustrative tissue configurations that may be formed with thegastroplasty devices and methods described herein.

FIGS. 6A and 6B show perspective and end views, respectively, of onevariation of a gastroplasty device, wherein the septum is in position.

FIGS. 7A and 7B show perspective and end views, respectively, of thedevice of FIG. 6A in an open configuration.

FIGS. 8A and 8B show perspective and end views, respectively, of thedevice of FIG. 6A in an open configuration with the septum removed.

FIGS. 9A and 9B show perspective and end views, respectively, of thedevice of FIG. 6A in a closed configuration.

FIGS. 10A to 10C show end views of the cartridge member and anvil memberduring delivery, during tissue acquisition, and prior to clamping of thetissue, respectively, in one example of how a clamping cable may berouted with respect to an optional septum.

FIGS. 10A and 11B show perspective and end views, respectively, ofanother variation of a suitable gastroplasty device.

FIGS. 11C and 11D show perspective views of a gastroplasty device withand without a septum, respectively.

FIGS. 12A to 12C show perspective views of yet another variation of agastroplasty device.

FIGS. 13A and 13B show cross-sectioned perspective and end views,respectively, of alternative acquisition pod assembly.

FIGS. 13C and 13D show cross-sectioned perspective and end views,respectively, of the device of FIGS. 13A and 13B under a high vacuumpressure.

FIGS. 14A to 14D show perspective views of the operation of anothervariation of a gastroplasty device utilizing parallel pod motion.

FIG. 14E shows a cross-sectional perspective view of a portion of thepod members in an open configuration with a septum still in placebetween the cartridge member and anvil member.

FIG. 15 shows a perspective view of yet another variation of agastroplasty device utilizing a translational trolley plate.

FIGS. 16A to 16D show side, end, bottom, and perspective views,respectively, of a variation of a gastroplasty device, which utilizes astatic acquisition pod.

FIG. 16E shows a bottom view of one variation of a gastroplasty devicehaving an arcuate configuration.

FIG. 17 shows a perspective view of a device having an optional featureof projections or serrations which may be defined along the matingsurfaces of the cartridge member and/or anvil member.

FIGS. 18A and 18B show perspective and cross-sectional end views,respectively, of another optional feature of one or more rotatableshafts which may be integrated into the device.

FIGS. 19A and 19B show perspective and detailed perspective views,respectively, of a device having a curved or adjustable segmented staplecartridge.

FIGS. 20A and 20B show perspective views of a septum assembly having atapered edge for facilitating removal of the septum from the hollow bodyorgan.

FIGS. 21A and 21B show perspective views of an alternative septumassembly having ribbed surfaces.

FIG. 21C shows a side view of one example of how collapse of the septummay be facilitated by withdrawing the septum into a receiving member.

FIGS. 22A and 22B show perspective and end views, respectively, of aseptum variation having at least two transverse septum members extendingto opposite sides of the longitudinal septum member.

FIG. 23A illustrates an end view of an extendable septum assemblypositioned between pod members and placed against stomach tissue.

FIGS. 23B and 23C show side views of variations for extending the septumassembly from a low profile delivery to an extended deployedconfiguration.

FIGS. 24A and 24B show end views of an alternative septum assembly whichmay be configured to deploy an extendable septum from a rolled-upconfiguration.

FIGS. 25A and 25B show perspective views of an alternative septumassembly having a collapsible septum member.

FIGS. 25C and 25D show end views of the septum of FIG. 25A in anexpanded or extended configuration and in a collapsed configuration.

FIGS. 26A to 26C show end, bottom, and perspective views, respectively,of yet another alternative septum having radiused corners.

FIGS. 27A and 27B show perspective views of an alternative septumassembly having a low profile delivery configuration where the septummay be comprised of two elongate T-shaped members.

FIGS. 28A to 28C show perspective views of an example of a clampingmechanism having two cam members.

FIG. 29A shows a perspective view of one example of how clamping cablesmay be routed through a gastroplasty device described herein.

FIG. 29B shows a cross-sectioned end view of a parallel clamping devicewith the septum shown.

FIGS. 30A and 30B show side and edge views of an alternativegastroplasty device, utilizing linked pod members.

FIG. 31 shows a perspective view of another variation of a gastroplastyassembly.

FIG. 32 shows a perspective view of sliding links joined together thatform an elongated tubular member for the gastroplasy assembly.

FIG. 33 shows a cross-sectional view taken along line 33-33 of FIG. 32.

FIG. 34 shows a variation of a tissue treatment device of a gastroplastyassembly in a delivery configuration with an endoscope alongside.

FIG. 35 shows the tissue treatment device of FIG. 34 with jaws opened.

FIG. 36 shows the tissue treatment device of FIG. 35 with the jawsopened and a retractor wire and sail in an extended configuration.

FIG. 37 shows a backside perspective view of the tissue treatment deviceof FIG. 36.

FIG. 38 shows a variation of a basket that may be disposed within avacuum pod of the tissue treatment device.

FIG. 39 shows a perspective view of a removable staple cartridge.

FIG. 40 shows a perspective view of the removable staple cartridgepositioned within a cartridge member of the tissue treatment device.

FIG. 41 shows a partial cross-sectional side elevational view of theremovable staple cartridge positioned within the cartridge member of thetissue treatment device.

FIG. 42 shows a planar view of an end ring that is connected to a distalend of the flexible elongated member.

FIG. 43 shows a partial cross-sectional view of the tissue treatmentdevice in a closed position.

FIG. 44 shows a partial cross-sectional view of the tissue treatmentdevice in an open position.

FIG. 45 shows a perspective view of a handle assembly.

FIG. 46 shows a partial cross-sectional view of the handle assemblyshown in FIG. 45.

FIGS. 46A and 46B show a push/pull mechanism disposed within the handleassembly.

FIGS. 47 through 53A show illustrative views and cross-sectional viewsof one method of forming a gastric sleeve in a stomach cavity.

FIG. 54 shows a perspective view of a variation of a stapler restrictor.

FIG. 54A shows a stapler assembly of the stapler restrictor in a closedconfiguration.

FIG. 54B shows the stapler assembly of the stapler restrictor in an openconfiguration.

FIG. 54C shows the stapler assembly of the stapler restrictor with arubber tip and removable staple cartridge removed.

FIG. 54D shows the stapler assembly of the stapler restrictor with ananvil member removed.

FIG. 54E shows the removable staple cartridge and rubber tip beingloaded into a cartridge member the stapler assembly.

FIGS. 55 through 57A show cross-sectional views of one method of forminga single fold of tissue near a distal stoma of a gastric sleeve tonarrow the distal stoma.

FIG. 58 shows a cross-sectional view of a gastric sleeve formed with onedual fold plication and restricted with three single fold plications.

FIG. 59 shows an illustration of a stomach cavity with two dual foldplications forming a long sleeve and two single fold plications alongthe lesser curve to narrow the gastric sleeve.

FIG. 60 shows an illustration of a stomach cavity with three dual foldplications forming a long sleeve and three single fold plications alongthe lesser curve to narrow the gastric sleeve.

FIG. 61 shows an illustration of a stomach cavity with four dual foldplications forming a long sleeve from the gastroesophageal junction tothe pylorus.

FIGS. 62 through 65 show another embodiment of a tissue treatment devicehaving a distal clamping wire passed around a distal vertical pulley.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Gastroplasty devices for tissue acquisition and fixation, and methods ofusing them are described. In general, the gastroplasty devices describedherein may be utilized for creating a partition within a hollow bodyorgan, such as the stomach, esophageal junction, and/or other portionsof the gastrointestinal tract. The gastroplasty devices may be advancedwithin a body through a variety of methods, e.g., transorally,transanally, endoscopically, percutaneously, etc., to create one orseveral divisions or plications within the hollow body organ, e.g., tocreate a gastric lumen within the stomach. Further, the gastroplastydevices may be assisted through the use of laparoscopic guidance, inparticular, visualization of the external surface of the hollow bodyorgan to assist in placement of the device, or within the organ cavityto monitor the procedure. Similarly, the devices of the presentinvention may be used in conjunction with other laparoscopic procedures,or may further be modified by an additional step or procedure to enhancethe geometry of the partition. For example, upon placement of apartition of the present invention, it may be desirable to perform asecondary step either transorally, or laparoscopically, to achieve thedesired gastroplasty geometry, such as the placement of a single fold orplication within the gastric lumen or pouch as described in U.S. patentapplication Ser. No. 10/188,547, which was filed Jul. 2, 2002 and isincorporated by reference herein in its entirety, to further restrictthe movement of food through the pouch, or the laparoscopic placement ofa band, clip, ring or other hollow reinforcement member at the outlet ofthe gastric lumen such as is done in a VBG, or lap-band procedure toreinforce or narrow the outlet of the lumen.

The gastroplasty devices described here, allow for the creation of asmaller gastric lumen to be achieved in a minimally invasive surgicalprocedure completely from within the stomach cavity. Moreover, thedevices described herein are configured such that once acquisition ofthe tissue is accomplished, any manipulation of the acquired tissue isunnecessary as the devices are able to automatically configure theacquired tissue into a desired configuration whereby the geometry of thedevices regulates or prescribes the resulting tissue geometry at thetime of acquisition. In operation, the perimeter of the device, and anyopenings therein, form the template or mold cavity around and into whichtissue flows, thereby creating a tissue structure that reflects thegeometry of the mold. That is, as the devices are configured such thatportions of the stomach wall are automatically positioned for fixationupon being acquired, and the tissue becomes automatically adjusted ortensioned around the perimeter of the distal working portion of thedevice in the stomach and within the distal working portion innervolume, to achieve the desired resulting geometry (e.g., small gastricpouch or restrictive partition or baffle). Because of the manner inwhich the tissue is acquired, the tissue intimately surrounds thecartridge member and anvil member to define or calibrate the subsequentvolume of the resulting gastric lumen. Thus, the gastric volume may bepredetermined by adjusting the volume of the cartridge member and anvilmember. As a result, once the desired volume is known and incorporatedin the device, the user can achieve a controlled acquisition and withoutintraprocedural adjustments or positioning requirements. Subsequentmanipulation of the tissue may be performed, if desired, to effectcertain configurations; however, this manipulation may be omittedentirely.

Turning to the figures, FIG. 1A shows a side view of one variation ofgastroplasty assembly 10. Assembly 10 may be generally comprised of anelongate tubular member 12 having handle assembly 16 connected at aproximal end 14. An integrated access assembly 18 may also be connectedat proximal end 14 for providing access to working lumen 22 definedwithin elongate member 12. Elongate member 12 may have a circular orelliptical cross-sectional area. Alternatively, the cross-sectional areamay take on any number of different cross-sectional configurations,e.g., hexagonal, octagonal, etc., provided that it presents anatraumatic surface to the tissue surfaces within the body. In addition,elongate member 12 may be curved, or may comprise a series of links asdescribed in U.S. patent application Ser. No. 10/686,326, which wasfiled on Oct. 14, 2003, and is incorporated by reference in its entiretyherein. In this way, a curved or flexible elongate member, or anelongate member comprising a series of links will help to increase theflexibility of the elongate member, and hence increase the ease in whichthe device is handled and operated. Working lumen 22 may extend entirelythrough tubular member 12 and may be sized to provide access to distalend 20 for various surgical tools or therapies once distal end 20 ofassembly 10 is positioned within a hollow body organ, and in particularmay be useful to place an endoscope or other visualization tool.Alternatively, a fiberscope or other type of visualization tool may beintegrated within the elongate member. Examples of useful scopes may bethe Olympus GIF P140, the Fujinon EG 25PE, and the like. Gastroplastydevice 24 is typically positioned at the distal end of tubular member 12and is also generally configured to be advanced atraumatically throughthe body of a patient and within a hollow body organ, e.g., esophagus,stomach, etc. Alternatively, an optional separate thin walledoversheath, may also be placed over the acquisition device, includingthe elongate member, to assist in placement, or may be placed over aguidewire or obturator down the esophagus prior to placement of thegastroplasty device and removed with the gastroplasty device once theprocedure is complete. The liner may be made of a thin wall polymer suchas polyolefin, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE),silicone and the like, having a wall thickness between 0.004″ and0.025″. This liner can serve to guide the gastroplasty device, as wellas help to limit trauma to the esophagus and other delicate structures.

FIG. 1B shows a closer detail view of the gastroplasty assembly 10. Asshown there, the device comprises a distal working portion, whichcomprises a cartridge member or pod 26 placed longitudinally inapposition to anvil member or pod 28. As described above, when thedevice is in use, the tissue of the stomach wall (including, in someinstances, the muscular tissue layers) are adjusted or tensioned aroundthe perimeter of the distal working portion, and within the distalworking portion inner volume, to achieve a desired resulting geometry(e.g., small gastric pouch or restrictive partition or baffle). Thus,the gastric volume may be predetermined by adjusting the volume of thedistal working portion, inner or outer profile. Cartridge member 26 maycontain one or several fasteners, e.g., staples, clips, etc., which maybe actuated via controls located proximally on handle assembly 16. Aseptum or barrier 32, described in further detail below, may beremovably positioned between cartridge member 26 and anvil member 28while connection member 30 may connect device 24 to tubular member 12.

Handle assembly 16 may be variously configured depending upon thedesired functionality to be implemented on assembly 10. In thisvariation, handle assembly 16 may generally comprise handle 34 for useby the surgeon or physician in advancing, withdrawing, or articulatingassembly 10. A control for articulating the device 24 between an openand closed configuration may be located on handle 34, shown as clampingcontrol knob 36, while a separate control mechanism, shown here asfastener firing lever 38, may be utilized for deploying the fastenerslocated within cartridge member 28. Although specific types of controlsare shown, these are intended only to be illustrative of the types ofcontrol mechanisms which may be utilized and are not intended to belimiting in scope.

Assembly 10 may further have one or several integrated vacuum ports 40proximally located on elongate member 12 for fluid connection to one orseveral vacuum pumps (not shown). One or each of cartridge 26 or anvil28 members may be fluidly connected through a common tube 12 or channelor through individually corresponding tubes or channels through elongatemember 12 to vacuum ports 40. Additionally, a scope seal housing 42configured to provide access to the working lumen 22 may also beoptionally provided near or at the proximal end of elongate member 12for the insertion of various tools and devices through elongate member12 for accessing the distal end of the assembly 10. An optionalauxiliary port 44 may also be provided for allowing fluid communicationvia a channel or tubing through elongate member 12 between the proximaland distal ends of the assembly 10. Auxiliary port 44 may be utilizedfor various purposes, e.g., delivery of fluids or gases into the hollowbody organ for transporting drugs or providing insufflation, etc. Asnoted above, the elongate body may be comprised of a series of links,similar to those described in U.S. patent application Ser. No.10/686,326, or of an extrusion fabricated with various lumens toaccommodate the various control wire and mechanisms of the acquisitiondevice. Similarly, the control mechanisms may be grouped together with aflexible band, and then sheathed in a thin skin sheath, such as heatshrink. The elongate member may also be a combination of an extrusionand a thin wall sheath to allow for flexibility, and may utilize braidedmaterials, e.g., stainless steel or superelastic materials such asNickel-Titanium alloy, integrated in the wall of the sheath to preventkinking and enhance torqueability.

A detailed view of one variation of the gastroplasty devices describedherein is shown in the perspective view of FIG. 2A. The cartridge member26 and anvil member 28, as described above, may extend longitudinallyfrom the distal end of elongate member 12 via connection member 30. Thecartridge member 26 and anvil member 28 may be both or singularlyarticulatable relative to one another or relative to elongate member 12.A pivot 50 longitudinally positioned between cartridge member 26 andanvil member 28 may be configured to enable the device to be pivotedinto an open configuration for the acquisition of tissue and a closed ordeployment configuration for delivery or advancement of the device intothe hollow body organ.

If both members 26,28 are articulatable, they may be configured to beeither simultaneously or sequentially articulatable. The cartridgemember 26 may contain a cartridge 52 container fasteners along an outeredge of the member 26 while the anvil member 28 may have an anvilpositioned along an outer edge of the member 26 such that the anvilcorresponds to the number and position of fasteners within cartridge 52.One or both members 26,28 may also define openings 56,58, respectively,along a portion of the length or the entire length of each of themembers 26,28. One or both of these openings 56,58 may be connected viatubing through vacuum lumens 60,62, respectively, defined throughelongate member 12 to the vacuum ports 40 located at the proximal end ofmember 12. Alternatively, a central vacuum lumen may supply both ports,or may bifurcate at the proximal or distal end of member 12. Elongatemember 12 may also define various cable lumens 64,66 for the passage ofcables for controlling the opening and closing of members 26,28 as wellas additional cable lumen 68 for the passage of cables for actuatingdeployment of the fasteners from within cartridge 52. Moreover, cablelumen 70 may be used for the passage of cables used for controlling theclamping of the members 26,28 towards one another.

Each of the members 26,28 may have openings 72,74 and 76,78,respectively, defined at the outer corners of each member opposite pivot50 to allow for the routing and passage of clamping cables through thedevice for enabling cartridge member 26 and anvil member 28 to beclamped closed towards one another. FIG. 2B shows a perspective view ofthe acquisition and fixation device of FIG. 2A with the vacuum tubingand cables routed through the device. As shown, vacuum tubing 80,82 maybe routed through elongate member 12 into a proximal end of one or eachof cartridge member 26 and/or anvil member 28 for fluid connection withrespective openings 56,58. Cables 84,86 may be utilized for opening andclosing the cartridge member 26 and anvil member 28 and cable 88, whichmay be routed into cartridge member 26, may be positioned and utilized,e.g., for pulling or pushing a wedge mechanism, to deploy fasteners outof cartridge 52. Moreover, clamping cables 90 may be passed throughelongate member 12 and routed through cartridge member 26 and anvilmember 28 such that cables 92,94 are passed through openings 72,74 and76,78 for clamping cartridge member 26 and anvil member 28 closed.Cables 84 and 86 may be replaced by torque shafts connected to handlesat the proximal end of the device, to open and close the cartridge andanvil members.

FIGS. 3A and 3B show perspective and end views, respectively, of across-sectioned portion 100 of a suitable gastroplasty device. As may beseen, septum 32 may be positioned to extend from pivot 50 effectivelyseparating vacuum openings 56,58 within cartridge member 26 and anvilmember 28, respectively. Adjacent to opening 56 is fastener cartridge 52and adjacent to opening 58 is anvil 54 positioned such that when septum32 is removed or displaced, the articulation of cartridge member 26 andanvil member 28 towards one another about pivot 50 positions cartridge52 in apposition to anvil 54. Alternatively, anvil member 28 cartridgemember 26 may be nonmovable or in a fixed position relative to thelongitudinal axis of the device. In this configuration, fastenercartridge 52 and optionally anvil 54, may be actuated to eject fromtheir respective housings to fasten the acquired tissue.

FIGS. 4A and 4B show representative illustrations of how gastroplastydevice 24 may be advanced transorally through the esophagus ES of apatient and positioned within stomach cavity SC of stomach 110. Makingreference now to FIG. 4A, device 24 may be articulated outside thepatient via handle 16 so that the proximal portion of elongate member 12may be positioned such that the spine of the device is placed against aportion of lesser curvature LC and opposite greater curvature GC. Inthis way, the device 24 extends between the gastroesophageal junctionGEJ towards pylorus PY. In addition FIG. 4A depicts the use of aflexible endoscope EN alongside the device 10 to allow directvisualization of the procedure, including the fixation step whereby thescope can then be removed, leaving additional volume remaining in thesmaller gastric pouch that may be helpful when removing or detaching thegastroplasty device 24 from the acquired tissue once it has been fixed.If no direct visualization is required, but additional removal volume isdesired, an optional expandable balloon, or other expandable member EMmay be used alongside the spine of the gastroplasty device, or may beintegrated into the spine of the gastroplasty device using knowntechniques. FIG. 4B shows the positioning of gastroplasty device 10without the aid of an endoscope, or other direct visualizationtechnique.

FIG. 5A shows an end view of device 24 positioned within stomach cavitySC with pivot 50 placed against stomach wall 120, for instance, againstlesser curvature LC in one example of how the device 10 may be used toeffect the creation of a gastric lumen or partition within stomachcavity SC. The device is advanced through the esophagus ES while in adeployment configuration, i.e., where the distal working portion of thedevice DWP is configured so that cartridge member 26 and anvil member 28are closed such that openings 56,58 and cartridge 52 and anvil 54 aredirectly positioned in apposition about septum 32. When desirablypositioned, one or both of cartridge member 26 and anvil member 28 maybe rotated about pivot 50 in the direction of the arrows shown. FIG. 5Bshows cartridge member 26 and anvil member 28 rotated at an angle with avacuum force activated within openings 56,58. In certain embodimentswhere no pivoting or movement of the cartridge member 26 or anvil member28 is necessary, the device is advanced in a static state. As seen,portions of the stomach wall 120 may be acquired and drawn withinrespective openings 56,58. The configuration of cartridge member 26 andanvil member 28 and the positioning of the device 24 within stomachcavity SC are such that this tissue acquisition procedure also enablesthe device 24 to be self-adjusting with respect to the acquired tissue122,124. More particularly, the device 24 is configured such thatportions of the stomach wall 120 are automatically positioned forfixation upon being acquired and the device 24 becomes automaticallyadjusted within stomach cavity SC relative to the stomach wall 120.Furthermore, because of the manner in which the tissue is acquired, thetissue intimately surrounds the cartridge member 26 and anvil member 28,i.e., the distal working portion of the device DWP, by being tensionedor held around the perimeter PT of the distal working portion of thedevice and within the inner volume IV of the distal working portion ofthe device to define the subsequent volume or resulting geometry RGresulting gastric lumen as shown by the diagonal and hatched linesrespectively in FIGS. 5F and 5G. An illustrative depiction of a crosssection of a resulting tissue geometry is provided in FIG. 5E. Otherdepictions of resulting tissue geometries are provided in FIGS. 5H and5I. Shown there are front views of the distal working portion of thedevice, and cross sectional views (along lines A-A and B-B respectively)of the resulting tissue geometries. In FIG. 5H, the distal workingportion has been configured to provide one plication P, whereas in FIG.5I, the distal working portion has been configured to provide more thanone plication. Multiple plications may be useful, for example, to helpincrease the ease in which the distal working portion of the device isremoved from a patient after tissue has been acquired and fixed. Thus,as these FIGS. illustrate, the gastric volume may be predetermined byadjusting the volume of the cartridge member 26 and anvil member 28, orgeometry of the distal working portion of the device, e.g., the distalworking portion of the device may be configured so that the gastrictissue has results in the geometries described, for example, in U.S.patent application Ser. No. 10/417,790, which was filed on Apr. 16, 2003and is hereby incorporated by reference in its entirety.

Optional septum 32 may act effectively as a barrier between openings56,58 to facilitate the acquisition of the tissue 122,124 into theirrespective openings 56,58 while minimizing or eliminating crossacquisition of the tissue into cartridge member 26 and/or anvil member28. In another alternative, septum 32 may be omitted from the device 24and acquisition of the tissue may be accomplished by sequentiallyactivating vacuum forces within openings 56 and 58. That is, thecartridge and anvil members may be orient towards the tissue surface ina sequential fashion, acquiring the tissue adjacent thereto. However,when a septum is employed, it may be removed from between cartridgemember 26 and anvil member 28 by translating the septum 32 distally,laterally, or proximally of cartridge member 26 and anvil member 28,after the tissue has been acquired. Alternatively, the septum may beleft within stomach cavity SC for later removal, or as will be describedin more detail below, may be left within the stomach cavity tobiodegrade. FIG. 5C shows septum 32 having been removed so thatcartridge member 26 and anvil member 28 may be pivoted from the openconfiguration back to its closed configuration in the direction of thearrows shown. Because the septum 32 has been removed, tissue region 126may now be presented for clamping between cartridge 52 and anvil 54.

As shown in FIG. 5D, cartridge member 26 and anvil member 28 may besimply clamped over tissue region 126 and fastened by deploying one orseveral fasteners from within cartridge 52. In acquiring the tissue122,124, manipulation of the tissue region 126 or the acquired tissue122,124 may be eliminated entirely due to the automatic positioning ofthe tissue for fastening. Once the clamped tissue has been fastened, thedevice 24 may be withdrawn entirely from the stomach cavity SC, as shownin FIG. 5E. As seen, one or several fasteners 128, e.g., a line ofstaples, may hold the tissue in its fastened configuration to result inthe creation of a partition, creating a restriction, or when desired,creating a gastric lumen or pouch 130, separate from the remainder ofthe stomach cavity.

Alternative variations of gastroplasty device 24 may also be utilized.For instance, FIG. 6A shows a perspective view of another variation indevice 140 partly cross-sectioned for the sake of clarity. In thisvariation, cartridge member 142 and anvil member 144 may define a curvedor arcuate shape. The septum may also be configured to have alongitudinal barrier portion 146 with a first transverse barrier 152 anda second optional transverse barrier 154. One or both barriers 152,154may extend in a curved or arcuate shape from the longitudinal septum 146such that an atraumatic surface is presented to tissue duringadvancement within the patient. The septum may be retained betweencartridge member 142 and anvil member 144 via septum detent 148 beingslidably positioned within septum retaining channel 150, which extendslongitudinally between cartridge member 142 and anvil member 144.Longitudinal septum 146 may partition openings 156,158, which mayfunction in the same manner as described above for adhering tissue. Itmay be advantageous to house a pressure transducer 159 near or withinthe pod(s) or opening(s), to allow the device user to accurately gaugemeasurement of pressure at the site of tissue adhesion. A drop ofpressure within the pod or opening signals to the user that the vacuumseal has been compromised, and therefore the amount of tissue adhered tothe system is not optimal. Readings from the transducer can serve asfeedback to the user that sufficient vacuum pressure has beenmaintained, and therefore be a “go-nogo” trigger to the user. FIG. 6Bshows a cross-sectional end view of the variation 140 from FIG. 6A. Asillustrated, cartridge 162 may retain one or several fasteners 166,shown in this variation as staples, in corresponding apposition to anvil164 when cartridge member 142 and anvil member 144 are in the closed ordelivery configuration. It should be noted that while a rectangularstaple jaw is depicted, it may be desirable to provide a curved track orwedge to facilitate the placement of a curved line of staples, from therectangular jaw. Pivoting member or plate 168, which may function tofacilitate the pivoting the device, may be seen as placed over the outersurface of cartridge member 142 and anvil member 144.

FIG. 7A shows a perspective view of an open configuration 170 of thedevice of FIGS. 61 and 6B for receiving tissue within openings 156,158.Septum 146 may be removed from the device by translating the septum 146longitudinally in the direction of the arrow. As shown in the end viewin FIG. 7B, pivoting region 160 may be seen expanded via pivoting plate168, which may be made from various biocompatible materials, e.g.,stainless steel, polymers, etc., and which is sufficiently flexible toenable the device to transition between the open and closedconfigurations. FIG. 8A shows the open configuration 180 in which theseptum 146 has been removed from the device. As described above, theseptum may be removed once the tissue has been acquired within theirrespective openings. FIG. 8B shows an end view of the device with theseptum removed. The tissue acquired within open region 182 may beclamped by articulating cartridge member 142 and anvil member 144 in thedirection of the arrows to result in the configuration shown in FIG. 9A,which shows the device 190 ready for fastening the clamped tissue withinclamping region 192. FIG. 9B shows an end view of the device configuredinto its closed configuration for fastening the tissue within clampingregion 192. As described above, because the stomach tissue may beautomatically configured for fastening once the tissue has beenacquired, manipulation of the tissue is rendered unnecessary duringclamping and fastening of the tissue.

In facilitating the clamping of cartridge member 142 and anvil member144 onto the tissue, clamping cables may be utilized, as describedabove. FIGS. 10A to 10C show end views of cartridge member 142 and anvilmember 144 during delivery, during tissue acquisition, and prior toclamping of the tissue, respectively, and one example of how clampingcable 200 may be routed with respect to septum 146. FIG. 10A showsseptum 146 in position between cartridge member 142 and anvil member 144with clamping cable 200 routed within a cable constraining slot 202defined in an adjacent portion of septum 146. The clamping cable 200 mayextend between cartridge member 142 and anvil member 144 throughclamping cable openings 204 defined in both cartridge member 142 andanvil member 144. Once the septum 146 is removed, as shown in FIG. 10C,the clamping cable 200 may be released from slot 202 and tensioned tobring cartridge member 142 and anvil member 144 towards one another, asdescribed in further detail below. Other mechanisms of clamping are alsosuitable, for example, the tissue may be clamped using hydraulic,pneumatic, or electropneumatic mechanisms, all of which are well knownin the art.

FIGS. 11A and 11B shows perspective and end view of another alternativegastroplasty device 210. This variation shows cartridge member 212 andanvil member 214 in a closed configuration with extension member 218connected to longitudinal pivot 216. The septum, in this variation, maycomprise a longitudinal septum member 220 and a perpendicularlypositioned transverse septum member 222, which may extend partially overthe openings 228, 230 when cartridge member 212 and anvil member 214 arein an open configuration, as shown in FIG. 11C. Respective vacuum tubing224,226 may be fluidly connected to one or both openings 228,230 definedwithin their respective members 212,214. FIG. 11D illustrates the devicewith the septum translated distally showing a clearer view of opening230.

FIGS. 12A to 12C show perspective views of yet another variation ofgastroplasty device 240. In this variation, cartridge member 242 andanvil member 244 may be pivotally connected via longitudinally definedpivot 246. Similar to the variation of FIGS. 11A and 11B, the septum mayalso comprise a longitudinal septum member 248 positionable betweenmembers 242,244 and an optional perpendicularly configured transverseseptum member 250. Also seen are vacuum tubing 252,254 fluidly coupledto their respective openings 260,262. As discussed above, because theresulting gastric lumen may be defined by the shape and volume of thedevice, cartridge member 242 and anvil member 244 may each definetapered distal ends 256,258, respectively, to provide an atraumaticsurface for advancement within the patient and to facilitate formationof a gastric lumen having a tapered distal region. The proximal shoulderof the members may also be tapered to facilitate removal of the deviceonce the procedure has been completed. Moreover, this variation alsoshows openings 260,262 which may be elongated to extend over a majorityof the length of their respective members 244,242.

Yet another variation of an alternative acquisition pod assembly 270 isshown in the cross-sectioned perspective view of FIG. 13A. Thisvariation may generally comprise pod walls 272,274 each defining anundercut section 276,278 having projections or serrations 280,282 alongtheir edges directed or angled towards one another. The assembly 270 maybe comprised of a biocompatible material, e.g., polymers,polycarbonates, etc., which has an elastic bending modulus sufficientlylow to allow for plastic deformation of the pod assembly 270 to occur. Abarrier 286 having a plurality of openings 288 defined over its surfacemay be positioned between pod walls 272,274 such that tissue acquisitionchamber 284 is defined as shown. A vacuum chamber 290 may be locatedbeneath barrier 286 with vacuum plenum 292 defined by chamber 290 andbarrier 286.

In operation, as shown in FIG. 13B, tissue 294 may be acquired againstor within acquisition chamber 284 by the application of a relatively lowpressure vacuum force applied through plenum 292, which may create a lowvacuum within chamber 284 through openings 288. Once the tissue 294 hasbeen first acquired, a higher pressure vacuum force may be appliedthrough plenum 292 such that pod walls 272,274 and undercut sections276,278, respectively, are plastically deformed and drawn towards oneanother in the direction of the arrows, as shown in FIG. 13C. As theundercut sections 276,278 are drawn inwards and shown in FIG. 13D, theacquired tissue 294 may become pinched at retained tissue region 296resulting in a temporary mechanical fixation of the tissue. A cessationof the high vacuum force may then result in a relaxation of the 20 podwalls 272,274 and ultimately of the release of the acquired tissue 294when the vacuum force is ceased altogether. Spearing mechanisms or aplurality of sharp hooks may also be used, in conjunction with, or inlieu of, the undercut sections described above.

Yet another variation of a gastroplasty device 300 is shown in theperspective views of FIGS. 14A to 14D. This particular variation mayutilize a parallel translational motion in moving the cartridge member306 and anvil member 308 between the open and closed configurationrather than a pivoting motion, as described above in other variations.As shown in FIG. 14A, device 300 may comprise pod assembly 302 connectedat the distal end of elongate tubular member 304. Septum 310 may beremovably positioned between cartridge member 306 and anvil member 308.A groove plate 312 defining a longitudinally extending slot may bepositioned adjacent to cartridge member 306 and anvil member 308 on aside opposite to that of septum 310.

FIG. 14B shows cartridge member 306 and anvil member 308 articulatedaway from one another into an open configuration while maintaining aparallel orientation relative to one another. In this openconfiguration, tissue may be acquired and drawn into respective podmembers 302 on opposite sides of septum 310. Groove plate 312, which maybe comprised of various biocompatible materials, e.g., stainless steel,polycarbonate, various polymers, etc., may be held stationary relativeto pod assembly 302 and may further help maintain cartridge member 306and anvil member 308 in their parallel orientation duringreconfiguration. FIG. 14C shows septum 310 removed from betweencartridge member 306 and anvil member 308 by being translated distallyvia septum control member 314, which may be articulated from a proximalend of elongate member 304. Once the septum 310 has been removed,cartridge member 306 and anvil member 308 may be articulated to clamponto the tissue while maintaining their parallel configuration, as shownin FIG. 14D. Once the tissue has been clamped, cartridge member 306 maybe actuated to fasten the tissue. FIG. 14E shows a cross-sectionalperspective view of a portion of pod members 302 in an openconfiguration with septum 310 still in place between cartridge member306 and anvil member 308. As shown, cartridge member 306 and anvilmember 308 along with acquisition chambers 316,318, respectively, may beseen maintaining a parallel configuration relative to one another.

FIG. 15 shows a perspective view of yet another variation of agastroplasty device 320 positioned upon the distal end of elongatetubular member 336. Similar to the device of FIG. 14A, cartridge member322 and anvil member 324 may be configured to open and close whilemaintaining a parallel configuration relative to one another. Optionalseptum 326 may also be positionable between members 322,324. However,device 320 may comprise a translationally movable trolley plate 328which may be advanced or retracted longitudinally. At least two wedgingmembers 330,332 may protrude from plate 328 at an angle whichcorrespondingly abuts with the distal ends of members 322,324 such thatwhen plate 328 is longitudinally translated, wedging members 330,332 maydrive cartridge member 322 and anvil member 324 towards one another in aparallel configuration to clamp onto any tissue which may have beenacquired by device 320. A septum groove 334 may be definedlongitudinally along the plate 328 so as to enable unhindered movementrelative to the septum 326. Cartridge member 322 and anvil member 324may also be configured such that when trolley plate 328 compresses themembers 322,324 onto tissue, fasteners are automatically deployed intothe tissue to fasten it.

FIGS. 16A to 16C show side, end, and bottom views, respectively, ofanother variation of gastroplasty device 340. Generally, while othervariations have enabled movement of respective pod members, thisvariation may maintain a static acquisition pod. Vacuum pod 342 may becomprised of a variety of biocompatible materials, e.g., polycarbonate,etc., shaped into opposing walls having vacuum plenums 348,350 definedalong the lengths of the opposing walls. While two vacuum plenums aredepicted, it should be understood that any number of vacuum plenums maybe employed as well. For example, a single vacuum plenum may be, used.Similarly, three or more vacuum plenums may be used. A septum having alongitudinal member 346 and an optional perpendicularly positionedtransverse member 344 may be positioned to fit within vacuum pod 342such that at least two tissue acquisition chambers 352,354 are formedalong the length of pod 342. Alternatively, the septum may only includelongitudinal member 346, and may omit any transverse members entirely,which may aid in reducing the overall profile of the distal working endof the device. The septum may generally be comprised of a similarmaterial as vacuum pod 342 and may be further coated with a layer of alubricious material, such as Teflon®. Furthermore, the septum may beformed of a bioabsorbable material that may either dissolve uponexposure to gastric fluids after tissue has been acquired, or may bereleaseably attached to pods or chambers and fixed in place betweentissue folds (e.g. left behind) once device is removed. The septum mayalso have end member 356 at one end of the septum which may act as astop for the device 340. FIG. 16D shows a perspective view ofacquisition device 340 revealing the vacuum plenum defined along thebottom of pod 342. While rectangular devices are depicted in FIGS.16A-16D, it should be understood that the device 343 can have a curvedor arcuate shape as well, as shown in FIG. 16E. Also depicted there areoptional septum 345 and a single vacuum plenums 347.

To facilitate the acquisition of the tissue, various features may beincorporated into any of the variations described herein. For instance,one optional feature may be seen in FIG. 17, which shows a perspectiveview of gastroplasty device 360 having a plurality of projections orserrations 366,368 defined along the mating surfaces of cartridge member362 and/or anvil member 364. Serrations 366,368 may be positionedadjacent to the cartridge and/or anvil to provide additional mechanicalsupport of the tissue positioned between clamped members of theacquisition device 360 during tissue fixation. Alternatively clearancecuts (not shown) on the cartridge may be included to reduce the surfacearea and required clamping force for fixation, as well as addingtraction to the system. As described above, spearing mechanisms, orsharp projections may be used as well.

Another optional feature which may be integrated with the devices hereinis shown in the perspective view of gastroplasty device 370 of FIG. 18A.A single pod member 372 is shown for illustrative purposes as thefeature of a rotatable shaft may be integrated into any of the devicesdescribed herein. Pod member 372 may define an opening 374 along itslength for receiving tissue therein, as described above; however, thedevice may also comprise at least one rotatable shaft 376 positionedlongitudinally within the pod member 372 adjacent to the opening 374.The rotatable shaft 376 may define one or several projections orserrations 378 along its surface such that tissue drawn into the opening376 via a vacuum force may also be mechanically acquired by rotation ofthe shaft 376 in a first direction to allow serrations 378 to becomeaffixed to the tissue. The shaft 376 may be rotated in a second oppositedirection to release the acquired tissue. Moreover, the pod member 372may acquire the tissue with the vacuum force alone, as described above,with the rotatable shaft 376 alone, or with a combination of both thevacuum force and shaft 376 operated in conjunction with one another.FIG. 18B shows a cross-section of pod member 372 having a secondrotatable shaft 380 also defining projections or serrations 382 alongits surface. In the case of two shafts utilized together, they may beconfigured to be counter-rotating such that the acquired tissue 384 isoptimally retained within opening 374. Likewise, to release the acquiredtissue 384, the shafts 376,380 may be counter-rotated in the oppositedirection.

Yet another feature which may be integrated with the devices herein isshown in the perspective view of FIG. 19A, which illustrates acquisitionand fixation device 390 having a single pod member for the sake ofclarity. Also shown are septum 400 and opening 402. A segmented staplecartridge 392 having an adjustable curvature and height may beintegrated into any number of the devices described above. Cartridge 392may be comprised of one or more staple cartridge segments 394 which arepivotally connected to one another via joints 396 which may allow notonly pivotal side-to-side motion between segments 394 but also heightadjustments relative to one another.

Each staple cartridge segment 394, as seen in the detail perspectiveview of FIG. 19B, may each define staple openings 398. In connectingwith adjacent cartridge segments 394, a radiused pivot member 404 mayextend from one side of the segment 394 and a receiving cavity 406 maybe defined in the opposite side of the segment 394. Each pivot member404 may extend away from segment 394 such that when positioned into acorresponding receiving cavity 406, adequate spacing exists betweensegments 394 such that side-to-side motion is possible between thesegments 394 to define a curvature of the resulting cartridge 392.Moreover, because of the translational fit between pivot member 404 andcavity 406, the heights of different segments 394 may be varied todefine a curve in the height of cartridge 392, as shown by heightdifferential Z in FIG. 19A and the height differences between adjacentsegments 394 in FIG. 19B. Accordingly, cartridge 392 may be varied inlength by varying the number of segments utilized, as well as varied incurvature and in height. The corresponding anvil member may be adjustedto accordingly match the curvature of the cartridge 392.

In addition to variations on types of pod members and tissue acquisitionenhancements, the septum may also be adjusted in various ways toaccommodate different devices and desired results. For instance,gastroplasty device 410 may be seen in the perspective view of FIG. 20Awith one variation of septum assembly 412 positioned between pod members422,424. Septum assembly 412 may be seen in better detail in theperspective view of FIG. 20B. In this variation, the septum may have atransverse septum member 414 perpendicularly positioned relative tolongitudinal septum member 416 extending from extension member 420, asdescribed above. However, this variation may define a tapered edge 418along the proximal edge of longitudinal septum member 416. This taperededge 418 may extend at an acute angle from extension member 420 towardstransverse septum member 414 to facilitate removal of the septumassembly 412 from within the hollow body organ.

Another alternative on septum variations is shown in the perspectiveviews of FIGS. 21A and 21B. Ribbed septum assembly 430 may generallycomprise transverse septum member 432, longitudinal septum member 434,tapered edge 440 extending between extension member 438 and transverseseptum member 432. However, the septum members 432,434 may be ribbed 436to facilitate collapse of the septum assembly 430 when withdrawn fromthe hollow body organ. The hardness and geometry of the septum assembly430 may be accordingly configured to provide adequate strength duringvacuum-assisted tissue acquisition yet flexible enough to collapse whenremoved from the patient. FIG. 21C shows one example of how collapse ofthe septum may be facilitated by withdrawing the septum into a receivingmember 442 having a tapered opening 444. As the septum assembly 430 ispulled into channel 446, the ribbed surfaces may collapse into a smallerconfiguration for withdrawal.

Another alternative septum variation 450 is shown in the perspectiveview of FIG. 22A. Longitudinal septum member 452 may have at least twotransverse septum members 454,458 extending to opposite sides oflongitudinal septum 452. Each of the transverse septum members 454,458may define a helical tapered edge 456,460, respectively, such thatremoval of the septum assembly 450 from the hollow body organ isfacilitated. FIG. 22B shows an end view of the septum assembly 450positioned between pod members 462,464.

Rather than using a perpendicularly-configured septum, an alternativemay be to utilize a septum member having only a longitudinally extendingmember which extends sufficiently high so as to preventcross-acquisition of tissue into the pod members. FIG. 23A illustratesan end view of an extendable septum assembly 470 positioned between podmembers 472,474 placed against stomach tissue 476. FIG. 23B shows a sideview of one variation for extending the septum assembly 478 from a lowprofile delivery configuration to an extended deployed configuration.Once septum assembly 478 has been advanced into a hollow body organ inits low profile configuration, the assembly 478 may be deployed into itsexpanded configuration. An extension septum member 480 may have a numberof projections 482,484 protruding from either side of extension 480. Acorresponding longitudinal septum base 486 may define channels 488,490through which projections 482,484 located on extension 480,respectively, may be translated within. Moreover, channels 488,490 maybe angled relative to a longitudinal axis defined by septum base 486such that distally advancing extension 480 relative to septum base 486raises extension 480 a distance away from base 486, effectivelyincreasing a height of the septum assembly 478. Projections 482,484 andchannels 488,490 may be covered so that travel of the extension 480 isuninhibited by surrounding tissue.

Similarly, FIG. 23C shows a side view of another septum assemblyvariation 492 in which extension septum member 494 is extendable frombase septum member 496. When advanced distally relative to longitudinalseptum base 496, extension 494 may travserse channels 498, which formramped channel portion 500, defined within base 496 to extend into aseptum assembly 492 having an increased height.

FIG. 24A shows another alternative septum assembly 510 which may beconfigured to deploy an extendable septum from a rolled-upconfiguration. As seen in the end view, septum assembly 510 is in adeployed configuration between pod members 512,514. Retractable septum520, may be extended from a rolled-up configuration within drum 516,which may be positioned between opposing transverse septum members 518.Cables 522 may extend from transverse septum members 518 for attachmentto pod members 512,514. After the tissue has been acquired, retractableseptum 520 may be retracted into drum 516 via manipulation of controlcable 524, as seen in FIG. 24B, to assume a low profile for withdrawalfrom the patient.

Another variation of septum assembly 530 is further shown in theperspective views of FIGS. 25A and 25B. Septum assembly 530 may comprisetransverse septum member 532 and collapsible septum member 534, whichmay be configured between a collapsed configuration and an extendedconfiguration. Transverse septum 532 may be elevated and loweredrelative to pod members 548,550 during delivery and deployment of septumassembly 530, e.g., via crossmembers 536,538 which may be configuredinto a scissors-type mechanism. Cross-members 536,538 may have itsproximal ends connected to control cable 542, which may be routedthrough extension member 544, while an intermediate portion of bothcross-members 536,538 may be pivotally connected to one another viapivot 540. Thus, articulation of control cable 542 from its proximal endby the surgeon or physician may actuate the scissors mechanism to eitherraise or lower transverse septum 532 in the directions of the arrow asshown. Transverse septum 532, when positioned between pod members548,550, may be secured via cables 546, as shown in FIG. 25B.

FIGS. 25C and 25D show end views of transverse septum 532 and thecollapsible septum member in an expanded or extended configuration 552and in a collapsed configuration 554. The collapsible septum member maybe enclosed by a biocompatible material to prevent pinching of tissue bythe cross-members 536,538. Moreover, the material covering thecollapsible septum may also be distensible, if desired. Variousmaterials may be utilized, e.g., nylon, polymeric materials, wovenmaterials made from various polymers, latex, elastomers, etc.

FIGS. 26A to 26C show end, bottom, and perspective views of yet anotheralternative septum 560. This particular septum 560 may be utilized withthe device 340 of FIGS. 16A to 16D. As shown, longitudinal septum 562may be perpendicularly and integrally connected with transverse septummember 564 at one end and base septum member 566 at an opposing end oflongitudinal septum 562. Transverse septum member 564 may defineradiused corners 568 at each of its four corners such that an atraumaticsurface is presented to the tissue during use within a patient.Moreover, septum 560 may be extruded or formed from a singular piece ofbiocompatible material (any of the biocompatible materials suitable forsuch a structure as discussed herein may be utilized) such that auniform structure is created.

FIGS. 27A and 27B show perspective views of an alternative septumassembly 570 which may also be utilized particularly with the device 340as discussed above. FIG. 27A shows septum 570 in a low profile deliveryconfiguration where septum 570 may generally be comprised of twoelongate T-shaped members. Each of the T-shaped members may be furthercomprised of longitudinal septum members 572,572′ and transverse septummembers 574′,574′, respectively. Each of the two elongate T-shapedmembers need not be uniform with one another depending upon the deviceinto which the septum assembly 570 is placed, but each member may bepivotally connected to one another via pivot 576 at a corner of adjacentlongitudinal members 572,572′. Thus, during delivery of the device andseptum 570 into the patient body, the low profile configuration of FIG.27A may be maintained and prior to or during tissue acquisition andfixation, one of the members, e.g., septum members 572′,574′ may bepivoted in the direction of the arrow such that the longitudinalportions of the septum 572,572′ contact one another to form anacquisition configuration 578 for the septum assembly, as shown in FIG.27B. After tissue acquisition and fixation, the septum may bereconfigured into its low profile configuration for removal from thepatient.

The septum in any of the above embodiments may be formed of abioabsorbable and/or biocompatible material such as polyester (e.g.,DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.),polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE),polyether ether ketone (PEEK), nylon, extruded collagen, silicone,polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), orpolyglycolic acid (PGA). Furthermore, it may be flexible, biocompatiblematerial which can either be left behind within the partition orexpelled distally, and either absorbed within the stomach, or digestedand expelled through the patient's gastrointestinal tract.

As discussed above, once the gastroplasty device has acquired theappropriate tissue, the device may be clamped upon the tissue to befastened. Clamping multiple layers of tissue to one another may requirea clamping mechanism which is configured to deliver a high degree ofclamping pressure. One example of such a clamping mechanism 580 is shownin the perspective views of FIGS. 28A to 28C, which show one variationfor opening the clamp. Clamping mechanim 580 may have attachment members582,584 for secure connection to each of a pod member. Each of theattachment members 582,584 may be connected to one another via rotatablecams 586,588, where each cam may have a rotatable pivot, 590,592,respectively, protruding therefrom. FIG. 28A shows clamping mechanism580 in a closed and clamped configuration while FIG. 28B shows themechanism 580 being initially opened. To open (or close) the mechanism580, cam 586 may be rotated by actuating a control cable 600, which maybe routed, for instance, through a tubular member 596 positioned withinthe elongate member 12, from its proximal end. Cam 588 may then berotated by actuating control cable 602, which may be routed withintubular member 598 also through tubular member 596. Because attachmentmembers 582,584 rotate about pivot 590, a channel 594 may be defined inmember 582 within which pivot 592 may translate when cam 588 is rotatedto effectuate clamping or opening of the pod members.

In addition to a cam mechanism 580, clamping cables may also beutilized, as discussed above. FIG. 29A shows a perspective view of oneexample of how clamping cables may be routed through an acquisition andfixation device 610. As seen, device 610 having pod members 612,614 maybe pivotable about longitudinal pivot 616. Although a pivoting device isshown in this variation, the routing of cables may be utilized in any ofthe other acquisition and fixation devices utilizing pivoting motion aswell as parallel clamping. A first clamping cable 620 may be routed intoone of the pod members, e.g., pod member 614, through positioning member630 mounted on pod member 614 and routed over pulley or radiused member622, also contained within pod member 614. First cable 620 may be looped632 adjacent to pivot 616 to allow for placement of the septum (notshown for clarity) and then anchored to clamping cable anchor 618.Likewise, second clamping cable 626 may be routed through positioningmember 630 adjacent to first clamping cable 620 and through pod member614 and over pulley or radiused member 628, also contained within podmember 614. Second cable 626 may also be looped 632 adjacent to pivot616 to allow for placement of the septum and then anchored to clampingcable anchor 624.

FIG. 29B shows a cross-sectioned end view of a parallel clamping devicewith the septum 634 shown. Like features are similarly numbered ascorresponding features from FIG. 29A. As in the pivoting variation,first 620 and second 626 clamping cables may be routed throughcorresponding tubular members 640 and the cables may be looped throughone or more slots 642 defined in septum 634 and subsequently routed intothe opposing pod member for anchoring. Clamping cables 620,626 arepreferably routed to facilitate the unhindered translation of septum 634as well as to ensure unobstructed access to openings 636,638 for thetissue to be acquired and fastened.

In yet another clamping variation, FIGS. 30A and 30B show side and edgeviews of an alternative gastroplasty device 650 utilizing linked podmembers. Cartridge member 652 and anvil member 654 may be connected toone another via linking arms 656,658 pivotally attached to one anothervia pivot 660 at one end of the device 650 and via linking arms 662,664also pivotally attached to one another via pivot 666 at the opposite endof the device 650. Clamping cables 672 may be routed through tubularmember 670 into the device 650 and over pulleys 674,676, as describedabove, for moving anvil member 654 between an open and closedconfiguration when acquiring tissue within acquisition region 668.Firing cable 678 may be manipulated to deploy the fasteners from withincartridge member 652 when anvil member 654 is clamped over the acquiredtissue. Deployment of the fasteners from cartridge member 652 may beachieved by incorporation of the firing wedge and other mechanisms astaught in U.S. Pat. No. 4,610,383, which is hereby incorporated byreference in its entirety. In addition, clamping may be accomplished viahydraulic, pneumatic, or electropneumatic mechanisms, as discussedabove.

Another variation of a gastroplasty assembly 700 is shown in FIG. 31.Assembly 700 may be generally comprised of an elongate tubular member702 having a proximal end 704 and a distal end 706 with a lumen 708defined within the elongate member. As shown in FIG. 31, a handleassembly 710 is connected at the proximal end 704 of the elongatemember, and a tissue treatment device 712 is attached at the distal end706 of the elongate member. The tissue treatment device is used to formeither single or dual fold plications within a stomach cavity.

The elongate member 702 may have a circular or ellipticalcross-sectional area. Alternatively, the cross-sectional area may takeon any number of different cross-sectional configurations, e.g.,hexagonal, octagonal, etc., provided that it presents an atraumaticsurface to the tissue surfaces within the body. In the embodiment shown,the elongate member 702 is a flexible shaft including a series ofsliding links 714 that increase the flexibility of the elongate member,and hence increase the ease in which the device is handled and operated.The lumen 708 may extend entirely through tubular member 702 and may besized to provide access to the distal end 706 for various surgical toolsor therapies once the distal end of assembly 700 is positioned within ahollow body organ, and in particular may be useful to place an endoscopeor other visualization tool. Alternatively, a fiberscope or other typeof visualization tool may be integrated within the elongate member.Alternatively, an optional separate thin walled oversheath, may also beplaced over the acquisition device, including the elongate member, toassist in placement, or may be placed over a guidewire or obturator downthe esophagus prior to placement of the gastroplasty device and removedwith the gastroplasty device once the procedure is complete. The linermay be made of a thin wall polymer such as polyolefin,polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), silicone and thelike, having a wall thickness between 0.001″ and 0.025″. This liner canserve to guide the gastroplasty device, as well as help to limit traumato the esophagus and other delicate structures.

FIG. 32 shows a perspective view of three sliding links 714 attached toone another. Several sliding links 714 are attached to one anotherdepending on the desired length of the elongate member 702. Typically,the length of the elongate member is determined by the anatomic lengthon a patient such that the distal end of the device reaches into thepatient's stomach while the proximal end extends out of the patient'smouth for a length sufficient to enable the user to manipulate thecontrols of the device, approximately 30 cm-80 cm long, for example 50cm-70 cm. Each sliding link 714 includes a circular outer surface 716with a first end 718 and a second end 720. In one embodiment, the firstend 718 of the sliding link includes four slots 721, and the second end720 includes four legs 722 that project parallel to the axis of thecircular outer surface of the links. The links are joined together byinserting the legs on one link into the slots of the adjacent link, andthen two legs 722 a opposite each other of one sliding link are bondedor adhered in the slots of the adjacent link. The remaining two legs 722b of an individual sliding link not bonded into slots are free to movewithin the slot of the adjacent link when the elongate member 702 iscurved as shown in FIG. 32. To allow for maximum flexibility, theposition of the bonded legs 722 a alternates with each sliding link 714.In other words, since all of the legs 722 of the sliding links arein-line with each other and there are four sets of legs that are in-linewith each other, every other leg in one of the four sets is bonded tothe adjacent link. When flexed, the bonded legs 722 a flex at a joint724 which also improves flexibility. The design of the sliding links 714also allow them to transmit torque along the length of the elongatemember 702. In one embodiment, a polyethylene tape is wrapped around theouter surface of the elongate member 702 to limit trauma to theesophagus and other delicate structures, while still allowing theelongate member to flex while limiting extensibility of the shaft. Othermaterials that may be used as coverings may include silicone, urethanes,or other polymers. In a further embodiment, such coatings may be sprayedon or applied as a coating or sheath, rather than wound as tape.However, it has also been contemplated that the elongated member 702 maybe formed using braided, molded, or slotted material, such as any metalor polymer. The elongated member may even be formed with a polymer thatdoes not includes links.

Referring now to FIG. 33, which is a cross-sectional view taken alongline 33-33 of FIG. 32, the internal cavity of the sliding link 714 isshown to include an inner arch 726 that divides the lumen 708 into anendoscope lumen 728 and a working lumen 730. The endoscope lumen issized so that an endoscope may pass there through. In one embodiment,the inner arch is only formed within every other sliding link in thechain that forms that elongate member 702 to help increase theflexibility of the elongate member. However, in another embodiment, theinner arch may be formed within every sliding link. The working lumen730 provides a passage for various cables for controlling the openingand closing of members 732 and 734 as well as additional cables foractuating deployment of the fasteners/staples from within the staplecartridge. Moreover, the working lumen 730 may be used for the passageof vacuum tubes connected to vacuum pods formed within the members 732and 734, and for the passage of retractor wires and septum wire (used toremove septum from between the members 732 and 734). These passagesprovided by the working lumen 730 prevent gross movements of the cablesand coil pipes, and also keep the endoscope free from entanglement. Theworking lumen within the elongated member allow small movements of thecables and coil pipes which may be important during bending of theshaft.

Referring back to FIG. 31, the tissue treatment device 712 attached tothe distal end 706 includes a cartridge member or jaw 732 placedlongitudinally in apposition to anvil member or jaw 734. When the tissuetreatment device is in use, the tissue of the stomach wall (including,in some instances, the muscular tissue layers) are adjusted or tensionedaround the perimeter of the distal working portion, and within thedistal working portion inner volume, to achieve a desired resultinggeometry (e.g., small gastric pouch or restrictive partition or baffle).Thus, the gastric pouch volume may be predetermined by adjusting thevolume of the tissue treatment device, inner or outer profile. Cartridgemember 732 may contain one or several fasteners, e.g., staples, clips,etc., which may be actuated via controls located proximally on handleassembly 710. A septum or barrier 736, may be removably positionedbetween cartridge member 732 and anvil member 734 while connectingmember or pin 738 may connect the device 712 to the tubular member 702.An atraumatic distal tip 740 can also be attached to the distal end ofthe tissue treatment device to limit trauma to the esophagus and stomachcavity. In this embodiment, the atraumatic distal tip is a splitflexible tip that opens and closes with the jaws 732 and 734 of thetissue treatment device. There is also a retractor wire 742 attached toa sail 744 that is extendible above the septum. The tissue treatmentdevice including the retractor wire and sail are described in moredetail with reference to FIGS. 76-80 of U.S. patent application Ser. No.11/282,320, which was filed on Nov. 17, 2005, and is hereby incorporatedby reference in its entirety.

In this embodiment, both members 732 and 734 of the tissue treatmentdevice 712 also define openings 741 and 743, respectively, along aportion of the length or the entire length of each of the members 732,734. One or both of these openings 741, 743 may be connected via tubingthrough elongate member 702 to the vacuum ports located at the handleassembly 710. Alternatively, a central vacuum lumen may supply bothports, or may bifurcate at the proximal or distal end of flexible member702. Targeted tissue can be sucked into these openings 741, 743 when avacuum is applied. To prevent tissue from becoming caught or snaggedonto the edges of the openings 741, 743, baskets 749 with holes can beplaced within the openings 741, 743. One embodiment of a basket 749 isshown in FIG. 38, that has rows of three holes per side, and with eachindividual hole measuring about 0.70 inch in width and about 0.060 inchin height. Baskets 749 with any number of rows of holes per side andwith a variety of sizes have also been contemplated. Also, to prevent“snagging” of tissue, the outside of the tissue treatment device isdesigned to be as smooth as possible. This allows tissue to “flow”around the device and into the openings. It may also be desired toeffect the outside shape so that the acquisition slows the flow ofcertain tissue to acquire more of a particular target tissue, i.e. slowthe flow of mucosa into the pod to allow more serosa to be gathered.

A detailed view of one embodiment of the tissue treatment device 712 isshown in FIGS. 34 through 36. The cartridge member 732 and anvil member734 may be both or singularly articulatable relative to one another orrelative to elongate member 12. A hinge 745 longitudinally positionedbetween cartridge member 732 and anvil member 734 may be configured toenable the device to be pivoted into an open configuration for theacquisition of tissue and a closed or deployment configuration fordelivery or advancement of the device into the hollow body organ. In oneembodiment, the retractor wire 742 extends from the proximal end 704 ofthe elongate member 702 to the tissue treatment device and through thehinge 745 that pivots the members 732 and 734. In an alternativeembodiment, the wire retractor extends through a strap 766 that isattached to the backside of the tissue treatment device.

As best shown in FIG. 36, a first end 746 of the retractor wire iscurved and includes an eyelet 747 that provides an attachment point foran end of a tether wire 748, which is attached to the sail 744 and theoptional septum 736 located between the cartridge member and anvilmember. In an alternative embodiment, the sail element may serve thefunction of the septum in its extended form. With the first end of theretractor wire secured to the tissue treatment device, the remainingportion of the retractor wire loops around the tissue treatment deviceand through the flexible elongate member 702, where the second end (notshown) is positioned at the proximal end 704 of the device 700. In theextended configuration as shown in FIG. 36, the sail acts as a barrierand ensures that the target tissue enters the appropriate vacuum podwithout crossing over into the other vacuum pod. It has also beencontemplated that that the tissue treatment device does not include aseptum, and the sail 744 is attached between the jaws of the tissuetreatment device. In this embodiment, the sail may be attached to thetissue treatment device with a pin or wire through the hinge locatedbetween jaws 732 and 734.

When the tissue treatment device 712 is in the delivery position withthe jaws 732 and 734 closed as shown in FIG. 34, the first end of thewire retractor rests inside a gap or slit 752 (see FIG. 35) formed inthe split flexible tip 740 and the sail is in a collapsed position sothat it is folded between jaws 732 and 734. In use, when the tissuetreatment device is positioned within the stomach, the retractor wire742 is extended by pushing the wire distally, and since the first end ofthe wire is anchored to the tissue treatment device via the tether,excess wire forms a loop 750 or other space occupying geometry withinthe stomach cavity. In this retraction position as shown in FIG. 36, theloop formed with the wire retractor pushes or blocks unwanted tissueaway from the tissue treatment device. In some embodiments, the wireretractor is a nitinol wire, although any material, including stainlesssteel or a comparatively stiff polymer, can be used to form the wirestructure. Extending the retractor wire 742 also raises the sail 744 bypulling the tether 748 away from the tissue treatment device. Targetedtissue is drawn into vacuum pods located in the cartridge member 732 andthe anvil member 734 when a vacuum is created, and the extended sail 744acts as a barrier to prevent tissue from crossing over from one pod tothe other. This helps to ensure that the plication or staple line formedin the stomach cavity is continuous without any gaps or holes.

In one embodiment, the shape of the sail 744 is defined by the tetherwire 748, which as shown in FIG. 36 is a triangle, although other shapesmay be used such as circular, oval, or any polygonal shape. The sail maybe formed of any flexible material, for example polyethylene tapeincluding polyethylene film with an acrylic adhesive, that is wrappedaround and secured to the tether, which in one embodiment may be aKevlar aramid line. Other materials that can be used to form the sailinclude any plastic or flexible material, for example the sail elementmay be cut from a sheet of material, or molded to a particular shape.Such other materials may include polyester (e.g., DACRON® from E. I. duPont de Nemours and Company, Wilmington, Del.), polypropylene,polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), nylon, orsilicone. In one embodiment, the tether 748 is also secured throughholes of the septum 736, however, the sail 744 may be attached directlyto the septum. It has also been contemplated that the first end 746 ofthe retractor wire 742 is directly attached to the sail without the useof a tether wire. Still in another embodiment, the retractor wire may beattached to the septum with the sail attached to the retractor wire andthe septum, as shown in one embodiment of U.S. patent application Ser.No. 11/282,320, which has already been incorporated by reference.

As shown in FIGS. 34-36, the split flexible tip 740 includes acylindrical body with a proximal end 754 and a distal end 756. The splitor gap 752 is formed at the proximal end of the cylindrical body and iswide enough to house the first end 746 of the retractor wire 742 whenthe device is in its delivery configuration. The cylindrical bodyincludes a progressive taper towards the distal end for insertionthrough the esophagus. Also, the cylindrical body may include a guidewire lumen 758 so the device can track along a guide wire that has beenpositioned within the stomach cavity. The proximal end 754 of the splitflexible tip 740 can be attached to the distal end of the tissuetreatment device 712 with an adhesive and/or mechanically with pins or apost extending from the tissue treatment device. If adhesive is used,the surface area at the cross section of the proximal end of thecylindrical body should be nearly as large as the surface area of theends of the jaws 732 and 734. The split or gap 752 allows the splitflexible tip 740 to open (see FIG. 35) and close (see FIG. 34) with thetissue treatment device 712, and provides a space for the retractor wireto extend through. In order for the split flexible tip to open and closeand be atraumatic to the tissue of the patient, it is formed of aflexible elastomeric material, such as silicone rubber.

As best shown in FIG. 37, an endoscope shroud or sleeve 760 is attachedto the backside of the tissue treatment device 712. The shroud 760provides a passageway for an endoscope EN, and the passageway startsfrom the distal end 706 of the flexible shaft or elongate tubular member702 and ends along the backside of the tissue treatment device 712. Itis possible for the shroud to extend any length along the tissuetreatment device, and it may even extend past the distal end of thetissue treatment device. In one embodiment, the tubular structure of theshroud is formed by layers of tape, such as polyester tape includingpolyester film with an acrylic adhesive, although any flexible materialmay be used to form the shroud. Other materials include polyethylenetape including polyethylene film with an acrylic adhesive, or polyimidetubing. In some embodiments the shroud may be molded or formed over amandrel and then attached to the tissue treatment device. It ispreferable that the shroud surface be smooth and flexible to beatraumatic to the esophagus when passed to the treatment area. A collar762 is attached to an end ring 764 located at the distal end 706 of theflexible shaft 702, and the proximal end of the shroud is attached to orwrapped around the collar as shown in FIG. 37. The shroud is thenattached to the tissue treatment device by being wrapped around a strap766 attached to the backside of the tissue treatment device 712 that mayalso provide a passageway for the retractor wire in some embodiments. Inother embodiments that do not include the strap 766, the shroud 760 canbe adhesively attached to the tissue treatment device. In use, theshroud tube lumen directs the endoscope EN around the jaws of the tissuetreatment device for viewing the procedure. Also, the shroud 760 cradlesor contains the endoscope to prevent the scope from torqueing orextending out of the insertion plane or extending into the lesser curveof the stomach organ which would affect the placement of the tissuetreatment device, or in a variety of directions that may impact theresulting geometry of the gastroplasty or pouch.

In one embodiment, the cartridge member 732 may contain a removablestaple cartridge 768 containing fasteners along an outer edge of themember 732 while the anvil member 734 may have an anvil positioned alongan outer edge of the member 734 such that the anvil corresponds to thenumber and position of fasteners within removable staple cartridge 768.The cartridge 768, which is shown in FIG. 39, is removable so thatduring a procedure, more than one staple line may be formed within thestomach cavity using the same gastroplasty assembly 700. Referring toFIG. 39, the staple cartridge 768 includes a staple housing 770 thatstores the staples, with a top end 772 and a bottom end 774. The top endincludes staple apertures 776 where the staples are ejected from tissue.To lock the removable cartridge 768 into the cartridge member 732, thehousing 770 includes a locking pin 778 attached to a flexing beam 780that is attached to the housing as shown in FIG. 39. There is also alift shelf 782 disposed within the housing 770 that provides an area tograb and lift the staple cartridge out of the cartridge member 732.Referring now to FIG. 40, the removable cartridge 768 is locked inposition within the cartridge member 732. As shown, the cartridge member732 includes a lock hole 784 that receives the flexible locking pin 778of the removable cartridge 768. The cartridge member 732 also includes alift clearance 786 that provides access to the lift shelf of theremovable cartridge 768. To remove a dispensed cartridge 768 from thecartridge member 732, an instrument can be inserted through the lockhole 784 to press or move the locking pin 778 away from and out of thelock hole. At the same time, another instrument can be inserted into thelift shelf 782 to pry the cartridge 768 out of the cartridge member 732.A full cartridge may then be placed into the cartridge member 732 sothat the locking pin 778 snaps into position within the lock hole 784.

To deploy the staples housed within the cartridge 768, a wedge 788 maybe pulled proximally through the cartridge member 732 via a stapleactuation wire 790. The actuation wire 790 may be manipulated at thehandle assembly 710 when staples are to be deployed into the tissue. Inone embodiment, as the wedge 788 is pulled proximally, the wedge engagesa staple pusher 792 that is disposed over corresponding staples 794, asingle staple pusher may be configured to engage multiple staples inadjacent rows. FIG. 41 shows the wedge 788 coming in contact with thestaple pusher 792. Pushers may be designed so that staples contact theanvil at different times optimizing the required force to fire thestaples. Alternatively, the spacing may be derived from tissue healingproperties. Or a combination of the two may effect the design of thepushers. The staple pusher 792 may include a sloped surface 796 forslidingly engaging the sloped surface of the wedge. As the wedge engagesthe sloped surface 796 of the staple pusher, the staple pusher is pushedtowards staples as the pusher is guided via one or more guides 798 tofire the staples.

Still referring to FIG. 41, the wedge 788 is disposed along a wedgeinsert 800, which is near the distal end of the cartridge member 732.The wedge insert 800 includes guides 802 that the wedge 788 follows whenit is initially pulled proximally to fire the staples. Before the deviceis activated and the staples are fired into tissue, the wedge 788 isstored along the wedge insert 800 where it does not engage or begin topush the stapler pusher 792 toward the staples. While the wedge 788 isin this starting position, it is also held in place during handling by ashear pin 804 that is molded into the staple cartridge 768. The shearpin 804 ensures that the wedge 788 does not begin to contact the staplesin the cartridge. In one embodiment, to move the wedge 788 proximallyout of the wedge insert 800 and past the shear pin 804, sufficient forceis provided to the wedge to break the shear pin away from the cartridge768 so that the wedge is free to move proximally along the cartridgemember 732. If after firing the staples of one staple cartridge 768 andthe tissue treatment device 712 is to be reloaded with another staplecartridge 768, the staple cartridge is removed as described above andthe wedge is pushed distally along the cartridge member 732 until it ispositioned back into its starting position within the wedge insert 800.It is important that the wedge is pushed back to the starting position,otherwise, when another cartridge is loaded into the device staples maybe pre-fired due to the position of the wedge. Then, another staplecartridge is loaded into the cartridge member 732, and the shear pin 804molded into this staple cartridge will hold the wedge in its startingposition during handling.

The tissue treatment device 712 is connected to the distal end of theelongate member 702 by connecting member 738 that is attached to an endring 808 disposed at the distal end of the elongate member. Across-sectional view of the end ring is shown in FIG. 42 and showsseveral apertures 810 disposed through the end ring to provide apassageway for the endoscope, vacuum tubes and wires. In one embodiment,the apertures are designated as follows: aperture 810 a is a passagewayfor the endoscope, aperture 810 b is a passageway for the cartridgemember vacuum tube, aperture 810 c is a passageway for the anvil membervacuum tube, aperture 810 d engages the connecting member 806 that isattached to the tissue treatment device, aperture 810 e is a passagewayfor the septum wire (discussed below), aperture 810 f is a passagewayfor the retractor wire, aperture 810 g is a passageway for the openingcable (discussed below), aperture 810 h is a passageway for the outerclamping cable (discussed below), aperture 810 i is a passageway for theinner clamping cable (discussed below), and aperture 810 j is apassageway for the staple actuation wire 790. In other embodiments, theapertures may be rearranged in any design and additional apertures maybe disposed through the end ring for additional wires.

Each of the members 732, 734 may have openings to allow for the routingand passage of clamping cables through the device for enabling cartridgemember 732 and anvil member 734 to be clamped together and opened. FIGS.43 and 44 show partial cross-sectional views taken along the tissuetreatment device 712 with the vacuum tubing and cables routed throughthe device. As shown, cartridge vacuum tube 812 and anvil vacuum tube814 may be routed through elongate member 702 into a proximal end ofeach cartridge member 732 and anvil member 734 for fluid connection withrespective openings 741, 743. Outer clamping cable 816 and innerclamping cable 818 may be passed through elongate member 702 aroundvertical pulleys 817 in the cartridge member 732 and across to the anvilmember 734 where the ends may be held in the anvil member with ballcrimps. To clamp cartridge member 732 and anvil member 734 closed, thecables 816 and 818 are pulled proximately. The closed configuration ofthe tissue treatment device 712 is shown in FIG. 43. Opening cable 822may be passed through elongate member 702 around the horizontal pulley823 in the cartridge member 732 and around an open cam 825 to the anvilmember 734, where the end is held in the anvil member with a ball crimp.Members 732, 734 may be opened with respect to one anther by pulling ortensioning the opening cable 822 proximately. This open configuration isshown in FIG. 44.

Referring now to FIGS. 45 and 46, the handle assembly 710 will bediscussed in detail. As shown in FIG. 45, the handle assembly 710includes a housing 824 having a transition knuckle 826 that attaches tothe elongate tubular member 702. There is a scope tube and seal mount828 which allows entry of an endoscope into the elongate member 702, anda vacuum tube adapter 830 which holds vacuum tubes 812, 814 and aninsufflation tube (not shown) so that the tubes may be connected to avacuum device. In one embodiment, this distal portion of the handleassembly 710 including the transition knuckle 826, the scope tube sealmount 828, and the vacuum tube adapter 830 is sealed pressure tight. Aclamp/open knob 832 is located at the proximal end of the handleassembly and is in connection with clamping and opening cables 816, 818,and 822. Twisting the clamp/open knob in a counter-clockwise directionopens the member 732, 734 of the tissue treatment device 712, andtwisting the clamp/open knob in a clockwise direction clamps the members732, 734 of the tissue treatment device closed. In one embodiment, thereare markings, such as, colored bands and/or numbers disposed on thehousing 824 of the handle assembly adjacent the clamp/open knob 832 toindicate the force being applied at the tissue treatment device 712.There is also a wedge fire knob 834 in this embodiment that is inconnection with the staple actuation wire 790. Turning the wedge fireknob in a clockwise directions causes the wedge 788 to move proximallywith in the cartridge member 732 to fire the staples 794. A wedge lock836 is disposed on the housing 284 near the wedge fire knob and is usedto lock the staple actuation wire 790 in position to prevent the wedge788 from being moved prior to forming a staple line within the stomach.In other embodiments, the wedge fire knob may be replaced with a leveror other activation means to pull the wedge within the cartridge member732. The handle assembly 710 also includes a retractor seal 838 to allowentry of the retractor wire 742 into the elongate member 702 (whilemaintaining the sealed portion of the handle). A proximal end of theretractor wire extends out of the retractor seal and the user may pushor pull the retractor wire during the procedure to extend and retractthe retractor wire within the stomach cavity. A groove 840 is alsodisposed on the housing 824 that tracks a septum push-off knob 842 thatmay be tightened to secure a septum wire attached to the septum 736. Theseptum push-off knob can be moved along the groove 840 to push theseptum wire distally, thereby removing the septum 736 from between themembers 732, 734 when needed, as will be described below. In oneembodiment, a septum key or lock is disposed near the proximal end ofthe tissue treatment device between members 732, 734 and fits within akey slot created along the proximal edge of the septum. The septum keyor lock prevents unwanted motion of septum during shaft flexing oraccidental actuation.

Referring now to FIGS. 46 through 46B, a push/pull mechanism 848 that isin connection with the clamp/open knob 832 and the cables 814, 816 and822 will be described. FIG. 46A shows the push/pull mechanism in anopened configuration when the jaws 732, 734 of the tissue treatmentdevice 712 are opened. To open the jaws, the opening cable 822 istensioned with respect to an open coil pipe 850. Tensioning isaccomplished by turning knob 832 counterclockwise, which pushes abalance bar pivot 852 against a slide link 854. This pushes a cross pin856 distally, which moves the open coil pipe distally and has the effectof tensioning the opening cable 822. When the knob 832 is turnedcounterclockwise, a lead screw 858, which is fixed rotationally,translates with the balance bar pivot and is pushed distally. Once thebalance bar pivot comes in contact with the slide link, an open thrustbearing 860 begins to compress open springs 862 in a spring holder 864.A colored line on the outside of the handle housing 824 is used todetermine the amount of compression and therefore the amount of tensionon the open cable.

FIG. 46B shows the push/pull mechanism 848 in a closed configurationwhen the jaws 732, 734 of the tissue treatment device 712 are clampedtogether. To close or clamp the jaws, the outer and inner clampingcables 816, 818 are tensioned with respect to clamp coil pipes 864.Tensioning is accomplished by turning the knob 832 clockwise, whichpulls the balance bar pivot 852 and the clamping cables 816, 818proximally, and redirects the cables through guide block 866. When theknob 832 is turned clockwise, the lead screw 858 is pulled proximally totension the clamping cables 816, 818. Once the clamp cables begin totension, a clamp thrust bearing 868 begins to compress clamp springs870. A colored line on the outside of the handle housing 824 is used todetermine the amount of compression and therefore the amount of tensionon the clamp cables 816, 818. Once the lead screw is pulled proximallyso that the balance bar comes out of contact with the slide link(s), thetension on the open cables is released. Lead screws can have variousthread pitches to create different clamp/open profiles. For example,constant thread pitch would cause the jaws to close at a consistentrate, but a varying pitch (along the lead screw) could generate sectionsof the travel to act quicker or slower, i.e. open fast, close slow, etc.

Referring to FIG. 46, the wedge fire knob 834 is attached to a wedgefire mechanism 872 that is attached to the staple actuation wire 790. Tofire the staples at the tissue treatment device 712, the knob 834 isturned clockwise to pull a lead screw 874 proximally into the knob. Thelead screw is rotationally fixed, but it is free to translate. Attachedto the lead screw is a wedge wire adaptor 876 that tensions the stapleactuation wire 790 and pulls the wedge 788 proximally. Before firing thestaples, the wedge lock 836 should first be loosened and removed from aguide pin located between the lead screw and the wedge wire adaptor.

In one embodiment, the gastroplasty assembly 700 may be transorallydelivered through the esophagus to create one or more plications withinthe stomach cavity. With reference to FIGS. 47-53A, one method of usingthe gastroplasy device will be described to form a sleeve or pouchwithin the stomach cavity.

In one embodiment, an endoscope EN my be introduced transorally to thestomach cavity to inspect the upper gastrointestinal tract and thestomach cavity. A guide wire GW may then be introduced through theendoscope to the stomach cavity and the endoscope may be removed fromthe patient. With the guide wire in position, a bougie dilator (notshown) is introduced over the guide wire to dilate the esophagus and thegastroesophageal junction (“GEJ”). The bougie dilator is removed and theproximal end of the guide wire is passed through the guide wire lumen758 of the distal tip 740 and the tissue treatment device 712 isintroduced through the esophagus and into the stomach cavity until thetissue treatment device is about 5 cm beyond the Z-line location asshown in FIG. 47. In one embodiment, there may be markings along thejaws 732 and 734 to properly position the tissue treatment device. Next,the guide wire GW is removed and the endoscope EN is inserted throughthe scope tube seal mount 828 of the handle assembly 710, the elongatemember 702, and the shroud 760. As shown in FIG. 48, the endoscope ENexits the shroud 760 and is retroflexed to view the tissue treatmentdevice 712 to verify that the proximal end of the jaws 732, 734 are atthe GEJ. In some embodiments, the stomach may be insufflated using theinsufflation tube for easier viewing with the endoscope.

With the endoscope EN still in position to view the tissue treatmentdevice 712, the jaws 732 and 734 are opened by rotating the clamp/openknob 832 counterclockwise. At this time the backside of the tissuetreatment device 712, the side including the shroud 760, should bepositioned against the lesser curve (“LC”) of the stomach cavity. Next,the retractor wire 742 is advanced by pushing the proximal end of theretractor wire through retractor seal 838 to retract the greatercurvature (“GC”) of the stomach with the excess loop of wire 750. Thisaction also deploys the sail 744 as shown in FIG. 49. At this stage, thevacuum tubes 812, 814 are clamped off and connected to a vacuum pump,which is then turned on. When the pump is stabilized at full vacuum,(between approximately 25 in Hg-30 in Hg, preferably 27 in Hg-29.5 inHg), the stomach is slowly desufflated and then the vacuum tubes 814,816 are opened to acquire tissue in each opening 741, 743 of thecartridge and anvil members 732, 734. It is preferred that the vacuumtubes 814, 816 are opened simultaneously, however, the vacuum tubes maybe opened at different times as well. The extended sail 744 and septum736 organize the target tissue into the appropriate member 732, 734.FIG. 49A depicts a cross-sectional view taken along line 49 a-49 a ofFIG. 49, with folds of tissue being acquired in the openings 741,743. Atthis point, the members 732, 734 are lightly clamped together byrotating the clamp/open knob 832 in a clockwise direction. It may bedesired to clamp off the vacuum tubes 814, 816 and then insufflate thestomach to view the acquired tissue that is being held with the members732, 734. It is desirable that the acquired tissue have no large foldsor pleats so that a smooth double sleeve can be formed with the device.

The stomach may then be desufflated once again and the vacuum tubes 814,816 are unclamped to re-apply vacuum that holds the tissue within theopenings of the members 732, 734. Next, the retractor wire 742 isretracted almost completely, until the first end 746 is near the distaltip 740 and the sail is collapsed as shown in FIG. 50. The members 732,734 are unclamped by rotating the clamp/open knob 832 counterclockwise,and the septum 736 is ejected from between the members. The septum isejected by unlocking the septum push-off knob 842, sliding the knob 842about an inch back or proximally in the groove 840, tightening the knob842 to capture a septum wire 844, and sliding the knob 842 forward toadvance the septum distally. This procedure is repeated until the septum736 is fully advance away from the tissue treatment device 712 as shownin FIG. 51. Once again, the members 732, 734 may be lightly clampedtogether, the vacuum lines 814, 816 are clamped off, and the stomach isinsufflated to inspect the clamp tissue to ensure the septum 736 isclear of the targeted tissue and that no large tissue folds of pleatsare present in the clamp line, and that the sleeve staple line does notshow signs of a large proximal stoma. If the appearance of the acquiredtissue is acceptable, the stomach cavity is desufflated and the vacuumlines 814, 816 are unclamped to re-apply vacuum. After desufflation, themembers 732, 734 are fully clamped together using the clamp/open knob832. With tissue clamped between the members of the tissue treatmentdevice 712, the dual folds of the tissue are stapled together byrotating the wedge fire knob 834 clockwise, which moves the wedge 788proximally within the cartridge member 732 to fire the rows of staples.FIG. 51A depicts a cross-sectional view taken along line 51 a-51 a ofFIG. 51, and shows the two folds of tissue being stapled together withthe tissue treatment device. Once completed, the jaws of the tissuetreatment device 712 are opened by rotating the clamp/open knobcounterclockwise, and the vacuum pump connected to tubes 814, 816 isturned off. To remove the acquired tissue from the tissue treatmentdevice, the acquired tissue may be flushed from the openings 741, 743 ofthe members 732, 734 with a sterile water bolus delivered via vacuumtubes 814, 816 with a syringe. Once the tissue is freed from the tissuetreatment device, the endoscope EN is straightened as shown in FIG. 52,and the members 732, 734 are closed together with the septum still inthe trailing position. The endoscope is removed from the gastroplastyassembly 700, and then the entire assembly is removed from the stomachcavity, leaving a sleeve 846 within the stomach as shown in FIGS. 53 and53A.

If a long sleeve, two or more sleeves or staple lines, is to be disposedwithin the stomach cavity, the removable staple cartridge 768 can bereplaced with a fresh staple cartridge, as described above, and theentire procedure can be repeated to form another sleeve. It is preferredthat there are no gaps between individual staple lines that form a longsleeve, and in one embodiment the staple lines of a long sleeve may beoverlapped (end to end) to minimize gaps between staple lines.

Also, it is possible to reload the tissue treatment device 712 of thegastroplasty assembly 700 and then turn the tissue treatment devicetowards the lesser curve of the stomach to form a dual fold staple linedown the lesser curve of the stomach. This procedure will narrow thesleeve formed by the two dual fold staple lines. In yet anotherembodiment, the tissue treatment device 712 can be used to form a singlefold staple line within the stomach cavity. In this embodiment, afterforming a dual fold staple line, the tissue treatment device may beturned toward the lesser curve of the stomach to form another stapleline. However, in this embodiment, a vacuum is only created in one ofthe vacuum openings 741 or 743 so that only one fold of tissue isacquired and then stapled to form a single fold staple line. This singlefold staple line may be used to further restrict the sleeve formed bythe initial dual fold staple line.

After forming plications within the stomach cavity using thegastroplasty device 700, a restrictor stapler 900 can then be used toperform a secondary step in a gastric sleeve or pouch formationprocedure. The restrictor stapler may be similar to the endoscopicstapler described in U.S. patent application Ser. No. 11/107,382, whichis incorporated by reference in its entirety. There are multiple usesfor the restrictor stapler, such as forming additional plications in thedistal end of a gastric sleeve, and in some situations close a stoma orfistula created by a gastric sleeve.

Referring to FIG. 54, the restrictor stapler 900 includes a staplerassembly 902 or cartridge assembly connected via a flexible shaft 904 orelongated body having a proximal end and a distal end to a staplerhandle 906. The stapler assembly includes a fixation member having astaple cartridge member 908, within which one or more staples arehoused, and an anvil 910 in apposition to stapler cartridge member usedto provide a staple closure surface when tissue to be affixed isadequately positioned between staple cartridge member and anvil. Anoptional smooth rubber tip 912 with a guide wire channel 914 may beattached to the distal end of the staple cartridge member. Theatraumatic tip 912 prevents injury to tissue when the device is advanceddown the esophagus, and the guide wire channel allows the fixationassembly to track down a guide wire. The staple assembly also includesan acquisition member for acquiring tissue. In one embodiment a vacuumpod 916 is attached or integrated into the staple cartridge member 908,and a vacuum line or tubing 917 extends from the vacuum pod, along theshaft 904 and to the handle 906. It is preferred that the overallinsertion diameter of the stapler assembly and flexible shaft plusendoscope is equal to or less than 54 Fr. In one embodiment, with thejaws 908, 910 closed, the maximum perimeter of the device is equivalentto about 15.1 mm diameter (0.595 inch or 45 Fr diameter). With the jaws908, 910 opened, the maximum perimeter of the device is equivalent toabout 17 mm diameter (0.668 inch or 51 Fr diameter).

With stapler assembly 902 connected at the distal end of flexible shaft904, the handle 906 is connected at the proximal end of shaft. Theflexible shaft 554 is configured to be curved, and in one embodiment canachieve a 4 inch bend radius with a low application of force. The handle906 may include a housing and grip 920 in apposition to an actuationhandle 922. In use, the handle 906 allows the surgeon or user to holdand manipulate the restrictor stapler 900 with grip 920 whilearticulating stapler assembly 902 between an open and closeconfiguration via the actuation handle 922. A lever or staple deploymentactuator 924 is also disposed on the handle 906 and is used to deploystaples from the stapler assembly 902. Moreover, the configuration ofthe handle 906 allows the surgeon or user to articulate the staplerassembly 902.

In one embodiment, the anvil 910 may be pivotally connected via a pivot926 to the end of flexible shaft 904 as shown in FIG. 54A. The staplecartridge member 908 may be configured to remain stationary relative tothe flexible shaft 904 while anvil 910 may be manipulated into an openand closed configuration with respect to flexible shaft and staplecartridge member. However, in another embodiment, the staple cartridgemember may be pivotally connected to the flexible shaft and the anvilremains stationary. In yet another embodiment, both the anvil and thestaple cartridge member can pivot into an open and closed configurationrelative to the flexible shaft. To manipulate the anvil 560 to an openand closed configuration, a circular or disk-shaped cam may be pivotallyattached about rotational pivot located on the side of the proximal endof stapler assembly 902, as described with reference to FIG. 31 in U.S.patent application Ser. No. 11/107,382. Actuation wires or cables may bewound about cam such that when cable is pulled, cam is urged to rotateclock-wise about rotational pivot. Actuation cables may be manipulatedfrom their proximal ends by the user. As cam is rotated in a clock-wisedirection, a portion of staple cartridge member 908 may be engaged bythe cam thereby forcing the anvil 910 to pivot into an openconfiguration. An additional cam may also be affixed on the oppositeside of stapler assembly 902 such that dual cams are configured to openand close simultaneously in parallel. As shown in FIG. 54B, when dualcams are used and the jaws 908, 910 are opened, the surfaces of the jaws908, 910 remain parallel to one another. This allows for better tissueacquisition between the jaws 908, 910.

In one embodiment as shown in FIG. 54C, the anvil 910 includes an anvilextension 928 disposed at the distal end of the anvil. The anvilextension contacts the ceiling of a pocket 930 disposed in the proximalend of the rubber tip 912 as shown in FIG. 54D. This keeps the distalend of the anvil in plane and forces the stapler cartridge 908 and anvil910 to open in parallel as shown in FIG. 54B. Referring to FIG. 54C, thestaple cartridge member 908 includes a cartridge extension 932 thatengages a cutout 934 (see FIG. 54E) located at the proximal end of therubber 912 to secure the rubber tip to the stapler assembly 902.

In one embodiment of the restrictor stapler 900, there are two rows ofstaple apertures 936 defined over the surface of the staple cartridgemember 908, as best shown in FIG. 54D. Staples are deployed through theapertures in a similar manner as described with reference to FIGS. 22Ato 23C of U.S. patent application Ser. No. 11/107,382, by pulling astaple actuation wire that in turn moves a wedge in contact with astaple pusher to fire a staple. In this embodiment, the lever or stapledeployment actuator 924 is depressed to pull the actuation wire in orderto fire the staples from the stapler assembly. The jaws 908, 910 of thestapler assembly 902 are closed, as shown in FIG. 54A, using theactuation handle 922, and then the staples may be deployed into theacquired tissue. Other variations may utilize fewer or greater than tworows of staple apertures.

In one embodiment of the restrictor stapler 900, the staple cartridgemember 908 can be re-loaded with a removable staple cartridge 938. Asshown in FIG. 54E, the removable staple cartridge may be integrated withthe rubber tip 912, so that they are loaded and unloaded from the staplecartridge member 908 together. The removable staple cartridge 938includes a detent pin 940 located near its distal end, that when placedinto the staple cartridge member 908, locks into a lock hole 942 locatednear the distal end of the staple cartridge member. To load theremovable staple cartridge 938 into the restrictor stapler 900, the jaws908,910 of the stapler assembly 902 are opened, and the lever or stapledeployment actuator 924 is raised to push a staple firing wedge to thedistal end of the device. If the wedge does not travel to the end of thedevice, the wedge may be manually pulled using forceps. In oneembodiment, firing cable struts can be disengaged from the lever and thelever can be lowered without moving the wedge from the distal location.The proximal end of the removable staple cartridge 938 may be insertedinto the staple cartridge member 908 and slid back, ensuring wedge doesnot pre-fire the staples. Once the removable staple cartridge 938 isabout 90% in place, the jaws of the stapler assembly are slowly closedto allow the anvil extension 928 to nest in the pocket 930 of the rubbertip. The removable staple cartridge 938 is then pushed down and back toensure it is completely in the staple cartridge member 908, and the jaws908, 910 are completely closed. As the rubber tip/removable staplecartridge are loaded onto the stapler assembly 902, cartridge extension932 will engage the cutout 934 of the rubber tip 912 and the anvilextension 928 will fit into the pocket 930 of the rubber tip, and thedetent pin 940 will snap into the lock hole 942. To unload or remove therubber tip/removable staple cartridge, the jaws are opened and thedetent pin 940 is pushed away from the lock hole 942 and the rubbertip/removable staple cartridge is removed by the user. The removablestaple cartridges 938 may include two rows of six staples, each having4.8 mm leg length with 3 mm backspan. The staple line length in thisembodiment is about 25.0 mm (0.984 inch), although the length of thestaple line may range from about 12.5 mm (0.492 inch) to about 50.0 mm(1.97 inch).

Generally, as shown in FIG. 55 the restrictor stapler 900 is advancedover a guide wire through the guide wire channel 914 of the rubber tip912 and down the esophagus to the stomach cavity, the stapler assembly902 is preferably in a closed configuration. Further, the restrictorstapler may be compatible with the side-by-side insertion of a 8.6 mmdiameter flexible endoscope EN or similar scope. The device will beaxially located by referencing external markings on the shaft of thedevice, or visually by using markings on the head of the staplerassembly 902 relative to the “z-line.” In terms of radial location, thedevice will be rotated and placed while under direct visualization.Alternatively, the user may rely on markings on the handle torotationally orient the device. Once the stapler assembly 902 is in thedesired position within the stomach cavity for placing a plication alongthe stomach wall, the guide wire is removed, and the stapler assemblymay be articulated into an open configuration as shown in FIG. 54B. Avacuum may then be created at the vacuum pod 916 to acquire a fold oftissue 918 between the staple cartridge member 908 and the anvil 910. Itis preferred that a vacuum device be used to achieve a vacuum level ofabout 27 in Hg to about 29.5 in Hg. After the vacuum level hasstabilized, the jaws of the stapler assembly 902 are then clamped closedover the tissue as shown in FIG. 56. The vacuum created at the vacuumpod 916 is shut-off, and the stomach cavity is insufflated to inspectand verify that the restrictor stapler is in the desired positionrelative to the distal end of the sleeve. If the position is acceptable,the stomach cavity is desufflated and vacuum is again created at thevacuum pod. The jaws of the stapler assembly 902 are then fully openedto complete the tissue acquisition and then held until the vacuumstabilizes. Once stabilized, the jaws of the stapler assembly are thenclamped closed over the tissue. It is preferred that the user waitsfifteen seconds and then the staples are deployed into the acquiredtissue to form a single fold plication. Vacuum is then released and thestapler assembly 902 is opened and the device is slightly advanced androtated to allow for the gastric tissue to pull free from the vacuumpod, or vacuum may be reversed to expel the tissue from the pod. Oncethe tissue is free, the device is withdrawn leaving the geometry shownin FIGS. 57 and 57A, which is a cross-sectional view taken along line 57a-57 b of FIG. 57. FIG. 57 is an illustrative view showing thelongitudinal plication or dual fold sleeve 846 and the single fold oftissue 918 created by the restrictor stapler 900 to decrease thediameter of the distal stoma DS. The staple cartridge member may bereloaded with another removable staple cartridge 940 for another firingif necessary. Multiple plications may be positioned using the restrictorstapler 900 anywhere within the stomach cavity or newly created gastricsleeve or pouch. For example, three additional single folds of tissue918 may be created near the distal stoma created by the dual fold sleeve846 as shown in FIG. 58.

By placing a single fold plication at the distal stoma of a sleeve, therestrictor stapler 900 may reduce the diameter of the distal stoma fromabout 0.5 cm to about 1.5 cm. For example, in a wet lab test usingcanine tissue, a 19 mm diameter sleeve (57 Fr or 0.75 inch diameter) wasreduced to 11.7 mm diameter (35 Fr or 0.46 inch diameter) by placing tworestrictor plications adjacent to each other at the distal end of the 19mm diameter sleeve. Therefore, these two restrictor plications removed7.3 mm (22 Fr or 0.29 inch) from the sleeve diameter. The final size ofthe distal stoma was smaller than the perimeter of the stapler assembly.In a further example, the restrictor stapler places a plication thattakes-up 15 mm (0.59 inches) of linear tissue. This would yield a 4.8 mmdiameter reduction (14.3 Fr or 0.188 inch diameter).

The gastroplasty device 700 and the restrictor stapler 900 can be usedtogether to form a variety of geometries, some of which are disclosed inU.S. patent application Ser. No. 11/107,382, which has already beenincorporated by reference. In addition, multiple dual fold sleeves 846may be placed consecutively in the stomach cavity to form a longergastric sleeve, and multiple single folds of tissue 918 can bepositioned within the longer gastric sleeve to reduce the diameter ofthe stoma. For example, FIG. 59 depicts two dual fold sleeves 846 placedconsecutively in the stomach cavity, with two single folds of tissue 918each placed near the distal end of the individual sleeves 846. FIG. 60depicts three consecutively placed sleeves 846 and three single folds oftissue 918 each placed near the dial end of the individual sleeves 846.Although not shown, the single folds of tissue 918 can be placedanywhere along the lesser curve LC or circumferentially within theformed pouch to further restrict the diameter of the pouch. In anotherexample as shown in FIG. 61, multiple sleeves 846 have been createdwithin the stomach cavity from the GEJ to the pylorus. No single foldsof tissue are shown in this example, however, it may be desirable toplace multiple single folds of tissue along the lesser curve LC of thestomach.

In other embodiments, the distal stoma DS of the gastric sleeve or pouchmay be further restricted by cinching the distal stoma together asdisclosed in U.S. patent application Ser. No. 11/056,327, which ishereby incorporated by reference in its entirety. In this embodiment,anchors may be placed circumferentially around the distal stoma, andthen cinched together using a wire attached to all of the anchors. Inanother embodiment, an intragastric band may be placed at the distalstoma to further reduce its diameter as described in U.S. patentapplication Ser. No. 11/067,598, which is hereby incorporated byreference in its entirety. Here, the intragastric band is attachedcircumferentially around the distal stoma, and then the band itselfcinches the distal stoma. It should be recognized that once the gastricsleeve or pouch is created, many methods may used to further restrictthe diameter of the distal stoma created by the sleeve or pouch.

Referring now to FIGS. 62 through 65, another embodiment of a tissuetreatment device 712 is shown to include a distal clamping cable 950 tohelp close or clamp the members 732, 734 together. In the embodimentshown, a proximal end of the distal clamping cable 950 is attached atthe handle 710 and a distal end of the distal clamping cable is attachedto the distal end of the tissue treatment device. As shown in FIG. 62,cartridge vacuum tube 812 and anvil vacuum tube 814 may be routedthrough elongate member 702 into a proximal end cap 952 of eachcartridge member 732 and anvil member 734 for fluid connection withrespective openings 741, 743. Proximal outer clamping cable 816 andproximal inner clamping cable 818 may be passed through elongate member702 around proximal vertical pulleys 817 in the cartridge member 732 andacross to the anvil member 734 where the ends may be held in the anvilmember with ball crimps. FIG. 64 shows the proximal end of the tissuetreatment device with the proximal end cap 952 removed showing theproximal vertical pulleys 817, and the proximal inner and outer clampingcables 816, 818 including coilpipes 958. In this embodiment, the distalclamping cable 950 is also passed through the elongate member 702 intothe tissue treatment device 712 around a distal vertical pulley 954 in adistal end cap 956 of the cartridge member 732 and across to the anvilmember 734 where the end may be held in the anvil member with a ballcrimp. FIG. 63 shows the distal end of the tissue treatment device withthe distal end cap 956 removed to show the distal vertical pulley 954.To clamp cartridge member 732 and anvil member 734 closed, cables 816,818 and 950 are pulled proximately. While the proximal cables 816 and818 provide a clamping force at the proximal end of the tissue treatmentdevice, the distal cable 950 provides a clamping force at the distal endof the tissue treatment device to provide a more even clamping forceacross the entire length of the tissue treatment device. Proximalopening cable 822 may be passed through elongate member 702 around theproximal horizontal pulley as discussed above with reference to FIGS. 43and 44.

In another embodiment, one of the proximal clamping cables 816 or 818can be re-routed to the distal vertical pulley 954 to become the distalclamping cable 950. This embodiment still provides a clamping force atthe distal end of the tissue treatment device without having to add anadditional cable to the system. Further, by not adding an additionalcable, the mechanism in the handle assembly 710 would be the same asdisclosed above with reference to FIGS. 46A and 46B.

In describing the system and its components, certain terms have beenused for understanding, brevity, and clarity. They are primarily usedfor descriptive purposes and are intended to be used broadly andconstrued in the same manner. Having now described the invention and itsmethod of use, it should be appreciated that reasonable mechanical andoperational equivalents would be apparent to those skilled in this art.Those variations are considered to be within the equivalence of theclaims appended to the specification.

1. A gastroplasty device used to place plications within a cavity,comprising: a flexible elongated member having a proximal end and adistal end, and a lumen disposed between the proximal end and the distalend; a handle attached to the proximal end; a tissue treatment deviceattached to the distal end of the flexible elongated member and having acartridge member opposite an anvil member, the cartridge member and theanvil member being movable between a closed position and an openposition relative to one another, and the cartridge member beingre-loadable with a removable staple cartridge.
 2. The device of claim 1,further comprising a retractor disposed along the tissue treatmentdevice and movable from a delivery configuration to a retractionconfiguration to move tissue of the cavity.
 3. The device of claim 2,further comprising a barrier disposed between the cartridge member andthe anvil member of the tissue treatment device.
 4. The device of claim3, wherein the barrier being connected to the retractor, the retractorextends the barrier from a collapsed configuration to an extendedconfiguration between the cartridge member and the anvil member of thetissue treatment device when the retractor moves from the deliveryconfiguration to the retraction configuration.
 5. The device of claim 4,wherein the retractor moves from the retraction configuration to thedelivery configuration, the retractor collapses the barrier.
 6. Thedevice of claim 3, wherein the barrier is flexible.
 7. The device ofclaim 2, wherein the retractor is a wire retractor.
 8. The device ofclaim 1, further comprising an atraumatic tip attached to the distal endof the tissue treatment device.
 9. The device of claim 8, wherein theatraumatic tip includes a cylindrical body with a proximal end and adistal end, and the proximal end of the atraumatic tip having a gapdisposed therein, wherein the proximal end of the atraumatic tip beingmoveable between an open position and a closed position in response tothe cartridge member and the anvil member of the tissue treatmentdevice.
 10. The device of claim 1, wherein the flexible elongated memberincludes individual circular links attached to one another.
 11. Thedevice of claim 10, wherein the circular links form a scope lumen thatprovides a passageway for an endoscope.
 12. A method of providingtherapy to the stomach cavity of a patient, comprising: inserting atissue treatment device transorally to the stomach cavity, the tissuetreatment device having a cartridge member opposite an anvil member, andthe cartridge member being loaded with a first removable staplecartridge; acquiring stomach tissue at a target region for treatmentwith the cartridge member and the anvil member of the tissue treatmentdevice; forming a plication within the stomach cavity using staples fromthe first removable staple cartridge; removing the first removablestaple cartridge from the cartridge member; inserting a second removablestaple cartridge into the cartridge member; and forming a secondplication within the stomach cavity using staples from the secondremovable staple cartridge.
 13. The method of claim 12, furthercomprising deploying a retractor disposed along the tissue treatmentdevice and movable from a delivery configuration to a retractionconfiguration to move portions of the stomach tissue relative to thetissue treatment device, allowing the target region of the stomachtissue to be treated with the tissue treatment device.
 14. The method ofclaim 13, further comprising extending a barrier disposed between thecartridge member and the anvil member of the tissue treatment device andmovable from a collapsed configuration to an extended configuration. 15.The method of claim 14, wherein the barrier is connected to theretractor.
 16. The method of claim 15, further comprising removing thebarrier from between the cartridge member and the anvil member beforeplicating the targeted tissue.
 17. The method of claim 12, furthercomprising viewing at least a portion of the target region of thestomach with an endoscope.
 18. A method of providing therapy to thestomach cavity of a patient, comprising: inserting a tissue treatmentdevice transorally to the stomach cavity, the tissue treatment devicehaving a cartridge member opposite an anvil member, the cartridge memberand the anvil member being able to move between a clamped position andan open position; acquiring stomach tissue at a target region fortreatment with of the tissue treatment device; clamping the cartridgemember and anvil member together grasping the acquired target tissue;inspecting the acquired target tissue to ensure that desired tissue isacquired; unclamping the cartridge member and anvil member in an openconfiguration; re-clamping the cartridge member and anvil membertogether grasping the acquired target tissue; and plicating the targettissue together to form a sleeve within the stomach cavity.
 19. Themethod of claim 12, further comprising insufflating the stomach cavityand deploying a retractor disposed along the tissue treatment device andmovable from a delivery configuration to a retraction configuration tomove portions of the stomach tissue relative to the tissue treatmentdevice, allowing the target region of the stomach tissue to be treatedwith the tissue treatment device.
 20. The method of claim 19, whereinacquiring stomach tissue with the tissue treatment device the stomachcavity is desufflated while the retractor is in the refractionconfiguration.
 21. The method of claim 18, wherein inspecting theacquired target tissue to ensure that desired tissue is acquired, thestomach cavity is insufflated.
 22. The method of claim 21, whereinunclamping the cartridge member and anvil member in the openconfiguration, the stomach cavity is desufflated.
 23. The method ofclaim 22, further comprising insufflating the stomach cavity afterwherein re-clamping the cartridge member and anvil member togethergrasping the acquired targeted tissue the stomach cavity is insufflatedfor re-inspecting the acquired targeted tissue and then the stomachcavity is desufflated before plicating the target tissue together toform the sleeve within the stomach cavity.
 24. The method of claim 18,wherein inspecting the acquired target tissue to ensure that desiredtissue is acquired, an endoscope is used to view acquired target tissue.25. The method of claim 18, wherein acquiring stomach tissue at a targetregion using a vacuum generated within vacuum pods disposed within thecartridge member and the anvil member.